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SALIKHOVA, Olena, and Daria HONCHARENKO. "DEVELOPMENT POLICY OF THE PHARMACEUTICAL INDUSTRY IN GERMANY: LESSONS FOR UKRAINE." Economy of Ukraine 2020, no. 10 (October 25, 2020): 63–86. http://dx.doi.org/10.15407/economyukr.2020.10.063.
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The evolution of the development of the German chemical and pharmaceutical industry from technology borrowing to endogenous innovations and becoming a global leader is shown. It is substantiated that the government of the country promoted the development of a new industry by increasing budget allocations for the training of scientific and industrial personnel; research subsidies; subsidies for transportation and raw materials. It is shown that the formation of large companies has provided economies of scale and accelerated development. The creation of specialized research institutes under the auspices of the government initiated public-private partnerships in research funding, industry associations helped mobilize the public to support the industry, and competent company managers and industry representatives together with prominent statesmen provided concerted action to strengthen its innovation potential. Cultivating the national consciousness that the purchase of German goods is the key to the welfare of the state has determined consumer preferences and has become a powerful stimulus to expand supplies to the domestic market. The introduction of high customs tariffs on finished medicines has provided protection for the new industry in its infancy. The close cooperation of banks with pharmaceutical companies has contributed to the implementation of investment and innovation projects and external expansion. The creation of cartels by chemical and pharmaceutical companies was an institutional response to the unprecedented phenomenon of industrialization and catching up in Germany. It is revealed that at the present stage the Government of Germany through national and regional programs continues to promote the development of technological and innovative potential of pharmaceuticals. The expediency of introduction of mechanisms of endogenization of production development of medicines and medical devices in Ukraine, and also expansion of sales in the domestic market through introduction of preferences at public purchases in the context of protection of essential interests of safety and health of the nation is proved.
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Schmidt, Axel, Dirk Köster, and Jochen Strube. "Climate Neutrality Concepts for the German Chemical–Pharmaceutical Industry." Processes 10, no. 3 (February 25, 2022): 467. http://dx.doi.org/10.3390/pr10030467.
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This paper intends to propose options for climate neutrality concepts by taking non-German international experiences and decisions made into account. Asia-Pacific and Arabic countries do have already same lessons learned by large-scale projects with regard to economic evaluations. Quite a few conceptual studies to generate the climate neutrality of the chemical–pharmaceutical industry in Germany have been published recently. Most of the studies differ even in magnitude but do not refer to or evaluate the other ones. These are all first theoretical feasibility studies. Experimental piloting is not far developed; only few and only stand-alone parts are operated, with no overall concepts. Economic evaluation is missing nearly completely. Economic analysis shows a factor 3 more expensive green technologies. Even if a large optimization potential of about 30% during manufacturing optimization is assumed as significant, cost increases would result. To make green products nevertheless competitive, the approach is to increase the carbon-source cost analogue, e.g., by CO2/ton taxes by around EUR 100, which would lead to about factor 3 higher consumer prices regarding the material amount. Furthermore, some countries would not participate in such increases and would have benefits on the world market. Whether any customs-duties policy could balance that is generally under question. Such increasing costs are not imaginable for any social-political system. Therefore, the only chance to realize consequent climate neutrality is to speed up research on more efficient and economic technologies, including, e.g., reaction intensification technologies such as plasma ionization, catalyst optimization, section coupling to cement, steel and waste combustion branches as well as pinch technology integration and appropriate scheduling. In addition, digital twins and process analytical technologies for consequent process automation would help to decrease costs. All those technologies seem to lead to even less personnel, but who need to be highly educated to deal with complex integrated systems. Research and education/training has to be designed for those scenarios. Germany as a resource-poor country could benefit from its human resources. Germany is and will be an energy importing country.
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Wulf, Stefan. "The Revista Médica project: medical journals as instruments of German foreign cultural policy towards Latin America, 1920-1938." História, Ciências, Saúde-Manguinhos 20, no. 1 (March 2013): 181–201. http://dx.doi.org/10.1590/s0104-59702013000100010.
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After the First World War, foreign cultural policy became one of the few fields in which Germany could act with relative freedom from the restrictions imposed by the Treaty of Versailles. In this context the Hamburg doctors Ludolph Brauer, Bernhard Nocht and Peter Mühlens created the Revista Médica de Hamburgo (as of 1928 Revista Médica Germano-Ibero-Americana), a monthly medical journal in Spanish (and occasionally in Portuguese), to increase German influence especially in Latin American countries. The focus of this article is on the protagonists of this project, the Hamburg doctors, the Foreign Office in Berlin, the German pharmaceutical industry, and the publishing houses involved.
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Honcharenko, D. O. "The Pharmaceutical Industry in New EU Member States: A Statistical Comparison with Germany. Lessons for Ukraine." Statistics of Ukraine 92, no. 2 (June 15, 2021): 26–38. http://dx.doi.org/10.31767/su.2(93)2021.02.03.
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Pharmaceutical production is a strategic sector of the EU economy. The authorities of Central and Eastern Europe (CEE) countries that became EU members in 2004 have been building up domestic pharmaceutical industries for purposes of production and distribution of medical drugs (MDs) and medical products (MPs), on the one hand, and government assistance to business entities and public procurement, on the other. The article’s objective is to assess the change in economic performance of the pharmaceutical industry in Poland, Hungary and Czechia after their accession to EU, to make a comparative statistical analysis with Germany, the leader of pharmaceutical production in EU, and to reveal key problems of this industry development in CEE countries, in order to elaborate recommendations for Ukraine on replication of best practices and avoidance of potential risks.
Results of research show that pharmaceutical producers (group 54 SITC Rev.4) in CEE countries have been focusing mostly on EU market, with Germany being their main partner. The turnover of high tech pharmaceutical goods in CEE countries has significantly grown after the accession to EU, along with the significantly grown imports of these goods and the increasing negative trade balance. Pharmaceutical companies in CEE countries could increase the salaries and the apparent labor productivity, but the gap between them and Germany in salary and productivity terms still remains too wide. In the studied CEE countries there has been significant increase in pharmaceutical R&D spending, but its estimated share remains quite low compared with average figures for EU (16.1%) and Germany (25.6%).
It is substantiated that because the future Agreement between the European Community and Ukraine on conformity assessment and acceptance of industrial products (ACAA agreement, or “Industrial visa-free regime”), which is being negotiated right now, will cover the pharmaceutical industry, the Ukrainian pharmaceutics will gain benefits only given the consolidated endogenous capacities of the industry and firmly established advantages of localization providing stimuli for European companies to create production facilities and R&D centers in Ukraine (including ones for contract-based R&D and productions). It is demonstrated that the inflow of investment and technologies from European pharmaceutical companies is capable of accelerating production start-up and exports of MDs and MPs (as time need not be lost for setting up all the links of the chain), thus adding up to the assets of Ukrainian producers (through transfer of knowledge and skills), but all the above cannot compensate for domestic efforts aimed at creating tangible and intangible assets in the industry. Given its Eurointegration context, Ukraine needs to pursue the policy of increasing the industry’s endogenous capacities and rely on the comprehensive approach (instead of focusing on MDs and MPs) that will cover the following key areas: biological and chemical ingredients, medical equipment, pharmaceutical fillers and packages, equipment and apparatus for pharmaceutical production. This is expected to reduce the dependence of Ukrainian pharmaceutics on imports and eliminate the problem of “truncated industrialization” that can cause structural imbalances, worsen the balance of payments and weaken the national currency.
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Uhl, Alexander, Axel Schmidt, Christoph Jensch, Dirk Köster, and Jochen Strube. "Development of Concepts for a Climate-Neutral Chemical–Pharmaceutical Industry in 2045." Processes 10, no. 7 (June 30, 2022): 1289. http://dx.doi.org/10.3390/pr10071289.
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Global primary energy consumption has increased tenfold over the course of the 20th Century, the availability of non-renewable energy is becoming scarce, and the burning of fossil fuels is leading to global warming. Climate change has now become tangible. The will to act against fossil fuels has become apparent in the western world, and in Germany in particular. This poses a particular challenge for the chemical and pharmaceutical industry, since, in the future, not only will the energy input, but also the feedstock, have to come from non-fossil sources. They must be replaced by carbon capture and utilization, and the exploitation of a circular economy. Concepts for a climate-neutral chemical–pharmaceutical industry have been developed and evaluated. Due to a high predicted consumption of renewable energies and an insufficient expansion of these, Germany will remain an energy importer in the future. The largest consumer in a climate-neutral chemical–pharmaceutical industry will be electrolysis for hydrogen (up to 81%, 553 TWh/a). This can be circumvented by importing green ammonia and cracking. This will require investments of EUR 155 bn. An additional benefit will be increased independence from fossil resource imports, as green ammonia can be produced in a multitude of nations with strong potential for renewable energies and a diversified set of exporting nations.
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Schosser, R. "Risk/Benefit Evaluation of Drugs: The Role of the Pharmaceutical Industry in Germany." European Surgical Research 34, no. 1-2 (2002): 203–7. http://dx.doi.org/10.1159/000048910.
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Vitols, Sigurt. "Shareholder Value, Management Culture and Production Regimes in the Transformation of the German Chemical-Pharmaceutical Industry." Competition & Change 6, no. 3 (September 2002): 309–25. http://dx.doi.org/10.1080/10245290215047.
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One of the greatest points of controversy in the recent literature in political economy is the extent to which “shareholder value” oriented institutional investors are drivers of change in national systems of corporate governance. This article argues that the key question is how management cultures shape managerial responses to pressures for change from capital markets. Empirical evidence for this argument is provided through an examination of changes since the mid-1990s at the “Big Three” German integrated chemical/pharmaceutical companies: Hoechst, Bayer and BASF. Despite facing similar demands from shareholder-value oriented investors, management at the three companies have pursued quite different strategies. The end result, however, may be the same from a production regime perspective, that is, the long-run withdrawal of “Big Pharma” from Germany as a location for R&D due to a more favorable institutional framework in the US.
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Theiselmann, Rüediger. "Aussenwirtschaftsrecht and corporate investments in Germany – new hurdles for foreign investors." German Law Journal 10, no. 11 (November 1, 2009): 1495–503. http://dx.doi.org/10.1017/s2071832200018344.
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The newAussenwirtschaftsrechtgenerates new insecurity with regards to M&A transactions: On the one hand every industry may be affected by a prohibition, whereas certain sectors (telecommunications, energy incl. oil or natural gas, universal postal services, railway nets, banks, pharmaceutical industry or chemicals industry) are presumably of special importance. On the other hand, vendors should preventively ask any potential buyers from abroad but also German based prospects (given the fact that external investors could be one of their main shareholders) for a written declaration that they comply with the new law or that they have received anUnbedenklichkeitsbescheinigungfrom the BMWi. Additionally, investors from outside the EU or EFTA seeking to purchase of at least 25 percent of a German enterprise should consider anUnbedenklichkeitsbescheinigungat an early stage, ideally in combination with passing on the complete transaction files to the BMWi. Only in this way is a high level of legal and transaction safety possibly achieved. Conversely, investors prepared to risk of prohibtion and considering the intended purchase as unproblematic should desist from an announcement to the BMWi but bear in mind that theBaFinor theBundeskartellamtcould inform the BMWi, thereby triggering an assessment.Due to the new law, the BMWi will get an improved overview of planned or ongoing M&A transactions in Germany, given that many investors or vendors will apply for anUnbedenklichkeitsbescheinigungas a precaution. But the German state gains this increased level of regulation only through significant administrative efforts.
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Dubois, Pierre, and Laura Lasio. "Identifying Industry Margins with Price Constraints: Structural Estimation on Pharmaceuticals." American Economic Review 108, no. 12 (December 1, 2018): 3685–724. http://dx.doi.org/10.1257/aer.20140202.
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We develop a structural model to investigate the effects of pharmaceutical price regulation on demand and on manufacturers’ price-setting behavior in France. We estimate price-cost margins in a regulated market with price constraints and infer whether these constraints are binding, exploiting cost restrictions across drugs, which come from observing the same drugs in potentially price-constrained markets (France) and in markets where prices are unregulated (United States and Germany). Our counterfactual simulations suggest that price constraints generated modest savings for anti-ulcer drugs in 2003–2013 (2 percent of total expenses), relative to a free pricing scenario, and shifted consumption from generic to branded drugs. (JEL C51, D24, I18, L13, L51, L65)
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Bruchhausen, Walter. "Between Foreign Politics and Humanitarian Neutrality: Medical Emergency Aid by the Two German States before 1970." Social History of Medicine 32, no. 4 (April 9, 2018): 819–42. http://dx.doi.org/10.1093/shm/hky019.
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Summary During the armed conflicts of decolonisation in Korea, Vietnam and the Congo in the 1950 s and 1960 s, both German states joined the competition between East and West by sending medical teams to conduct aid work. West German numerical advantages in funds and available staff were countered by East German governmental command of human resources and productive capacities such as the pharmaceutical industry. As a result, the German Democratic Republic (GDR) preferred shorter stays and the supply of large amounts of equipment and materials whereas the Federal Republic of Germany (FRG) instead commissioned teams of NGOs for several years and financed whole facilities. Ideological or even distorted interpretation of facts was more obvious in the East, opposition of health workers to the official line of their respective governments in the West. The FRG also introduced a distinction between neutral humanitarian and politically interested development aid whereas for the GDR all work was solidarity with socialist or liberated countries.
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Schmäl, Christine, Katja Becker, Ruth Berg, Michael Brünger, Gerd Lehmkuhl, Klaus-Ulrich Oehler, Thorsten Ruppert, Claus Staudter, Götz-Erik Trott, and Ralf W. Dittmann. "Pediatric Psychopharmacological Research in the Post EU Regulation 1901/2006 Era." Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie 42, no. 6 (January 1, 2014): 441–49. http://dx.doi.org/10.1024/1422-4917/a000322.
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Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed “off-label” because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902/2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups. Furthermore, initiatives such as the European 7th Framework Program of the European Union now offer substantial funding for pediatric pharmacological research. At a recent Congress of the German Society for Child and Adolescent Psychiatry and Psychotherapy (DGKJP), experts from the field and the pharmaceutical industry held a symposium with lay representatives in order to discuss attitudes toward, and experience with, pediatric psychopharmacology research in Germany since 2007. Several areas of concern were identified. The present paper derives from that symposium and provides an overview of these opinions, which remain crucial to the field. A wider discussion of how to facilitate psychopharmacological research in Germany in order to optimize the treatment and welfare of children and adolescents with psychiatric disorders is now warranted.
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Schmidt, Axel, Lukas Uhlenbrock, and Jochen Strube. "Technical Potential for Energy and GWP Reduction in Chemical–Pharmaceutical Industry in Germany and EU—Focused on Biologics and Botanicals Manufacturing." Processes 8, no. 7 (July 11, 2020): 818. http://dx.doi.org/10.3390/pr8070818.
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European policy demands climate neutrality by the year 2050. Therefore, any manufacturing optimization needs to be achieved in the well-known pareto of global warming potential (GWP) reduction combined with cost of goods (COG) reduction at increasing product amounts, while still being able to compete in the world market. The chemical–pharmaceutical industry is one of the most energy-intensive industries. The pharmaceutical industry operates with low batch sizes, but high margins. This study analyzes, based on the literature and Bundesministerium für Wirtschaft und Energie (BMWi; English: Federal Ministry for Economic Affairs and Energy)-funded project results, the technical potentials for energy and GWP reduction, while focusing on biologics and botanicals, because those are already widely based on natural raw material resources. The potential impact for green technologies is pointed out in relation to climate-neutral manufacturing.
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Höfer-Bosse, T., and W. Scharmann. "Numbers of Animals Used in Toxicological Experiments—With Particular Reference to the Federal Republic of Germany." Alternatives to Laboratory Animals 13, no. 3 (March 1985): 212–19. http://dx.doi.org/10.1177/026119298501300309.
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Less than a quarter of all experimental animals in Europe are used in toxicological experiments, and most of these are performed by the pharmaceutical industry. Acute toxicity testing, mainly LD50 tests, accounts for a large proportion of toxicological studies. There are no defined animal numbers for special safety requirements in the Federal Republic of Germany (FRG). However, where the registration of chemical products in the FRG is concerned, numbers of animals used are documented.
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Honcharenko, D. О. "New ApproacheThe pharmaceutical industry’s R&D expenditure at the global level in 2007–2018 is analyzed. Two-thirds of the global pharmaceutical companies’ spending on R&D are accounted for s to the Assessment of Foreign Trade in High-Tech Pharmaceuticals." Statistics of Ukraine 88, no. 1 (May 1, 2020): 35–41. http://dx.doi.org/10.31767/su.1(88)2020.01.04.
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The pharmaceutical industry’s R&D expenditure at the global level in 2007–2018 is analyzed. Two-thirds of the global pharmaceutical companies’ spending on R&D are accounted for by 20 multinationals companies located mostly in the U.S. and EU.
With low level of R&D funding, Ukraine cannot produce cutting-edge pharmaceutical technologies. Imports of intermediate goods for pharmaceutical industry are the most widely used and most influential channel for attracting advanced technologies. The aggregation of high-tech goods by functional purpose (high-tech capital goods, high-tech intermediate and high-tech consumer goods) is analyzed. This aggregation is made by combining the Classification by Broad Economic Categories by SITC Rev. 4 (UN Statistics Division) and the High-Tech Aggregation SITC Rev. 4 (Eurostat). Based on this approach, the article identifies a range of high-tech pharmaceutical goods that are essential for pharmaceutical production, and introduces the concept of “high-tech pharmaceutical intermediate goods”. The author compiled a nomenclature of high-tech pharmaceutical intermediate goods by SITC Rev.4 (17 nomenclature positions with 6 digits). For the first time, this statistical tool made it possible to estimate the scale of national economy spending on advanced foreign technology embodied in commodities that are inputs in the pharmaceutical industry.
New indicators are proposed: “ratio of import dependence of pharmaceutical production”, “‘purified’ exports of pharmaceutical goods” and “coverage ratio of imports of high-tech intermediate pharmaceutical goods”; their algorithms are given and used in the author’s calculations for Germany (strong innovator), Poland (moderate innovator), and Ukraine as a country with low level of technological innovation in the analyzed field. The author recommends using the proposed new indicators for statistical monitoring and analysis of the effectiveness of science & technology and innovation policy measures aimed at building competitive pharmaceutical industry in Ukraine, reducing its dependence on imports and enhancing its export potential.
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L., J. F. "ATTITUDES TO RANDOMIZED TRIALS (1970S)." Pediatrics 93, no. 6 (June 1, 1994): A44. http://dx.doi.org/10.1542/peds.93.6.a44.
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Medical education in the Protestant North West has for some time been more scientific than elsewhere. There are, however, still problems. There is resistance to the idea of randomised controlled trials in West Germany. An attempt was made to have them declared illegal. After lecturing in Germany on the value of randomised controlled trials in cardiovascular medicine, and after a rather violent discussion, I was taken aside by the chairman, who said, "Dr. Cochrane, you don't seem to understand. Controlled trials are done by the pharmaceutical industry. Gentlemen don't do them." It is difficult to interpret this particular remark, but I suspect that the feeling of shame about the Nazi medical pseudo-experimentation may be a factor.
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FESTEL, GUNTER. "SIMILARITIES OF SUCCESSFUL TECHNOLOGY TRANSFER THROUGH NEW VENTURES." International Journal of Innovation Management 19, no. 02 (April 2015): 1550025. http://dx.doi.org/10.1142/s1363919615500255.
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Especially established industries, like the chemical and pharmaceutical industry, rely on effective and efficient technology transfer to maintain their competitiveness. Academic spin-offs, corporate spin-outs, and internal start-ups, as different types of new ventures, can be used for technology transfer from universities and research institutions to companies as well as between or within companies. Especially internal start-ups are a new approach for company internal technology transfer from research departments to business units. Based on 12 case studies from the chemical and pharmaceutical industry in Germany and Switzerland, which were identified and developed by narrative interviews with new ventures and parent organisations, like companies, universities, and research institutions, technology transfer through new ventures has been analysed. Despite the various backgrounds and challenges, the different types of new ventures show much more similarities than dissimilarities. Therefore, learnings from academic spin-offs can be transferred to corporate spin-outs and internal start-ups in the context of technology transfer.
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Liebenau, Jonathan. "Ethical Business: The Formation of the Pharmaceutical Industry in Britain, Germany, and the United States Before 1914." Business History 30, no. 1 (January 1988): 116–29. http://dx.doi.org/10.1080/00076798800000007.
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Holzmann-Littig, Christopher, Matthias Braunisch, Peter Kranke, Maria Popp, Christian Seeber, Falk Fichtner, Bianca Littig, et al. "COVID-19 Vaccination Acceptance and Hesitancy among Healthcare Workers in Germany." Vaccines 9, no. 7 (July 12, 2021): 777. http://dx.doi.org/10.3390/vaccines9070777.
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Vaccination hesitancy is a threat to herd immunity. Healthcare workers (HCWs) play a key role in promoting Coronavirus disease 2019 (COVID-19) vaccination in the general population. We therefore aimed to provide data on COVID-19 vaccination acceptance/hesitancy among German HCWs. For this exploratory, cross-sectional study, an online survey was conducted in February 2021. The survey included 54 items on demographics; previous vaccination behavior; trust in vaccines, physicians, the pharmaceutical industry and health politics; fear of adverse effects; assumptions regarding the consequences of COVID-19; knowledge about vaccines; and information seeking behavior. Odds ratios with 95% confidence intervals were calculated and chi-square tests were performed. Four thousand five hundred surveys were analyzed. The overall vaccination acceptance was 91.7%. The age group ≤20 years showed the lowest vaccination acceptance. Factors associated with vaccination hesitancy were lack of trust in authorities and pharmaceutical companies. Attitudes among acquaintances were associated with vaccination hesitancy too. Participants with vaccination hesitancy more often obtained information about COVID-19 vaccines via messenger services or online video platforms and underperformed in the knowledge test. We found high acceptance amongst German HCWs. Several factors associated with vaccination hesitancy were identified which could be targeted in HCW vaccination campaigns.
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Toktonalieva, N., and I. Toktonaliev. "History and Background of the Implementation of Good Manufacturing Practice Standards in the Pharmaceutical Industry (Review)." Bulletin of Science and Practice 6, no. 9 (September 15, 2020): 182–91. http://dx.doi.org/10.33619/2414-2948/58/17.
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The volume of the global pharmaceutical market in 2018 amounted to 1.2 trillion US dollars, and by 2020 the global pharmaceutical market has grown to 1.5 trillion dollars. Countries such as the United States, Japan, Germany, Switzerland and Great Britain took the leading positions in the pharmaceutical market, while the market share of the member states of the Eurasian Economic Union (EAEU) in the world community was 2.6%. Further growth of the global pharmaceutical market is predicted by 5% annually, which may contribute to the rapid production and distribution of low-quality pharmaceutical products. One of the main goals of the country is to provide the population with effective, high-quality and safe medicines drugs to protect their health, since consumers cannot assess the quality of medicines on their own. To accomplish this task in developed and developing countries, the state regularly checks and evaluates the quality, efficacy, safety, as well as the main pharmacological effects of drugs at all stages of production. In the production of drugs, it is necessary to comply with the rules of Good Manufacturing Practice. Good Manufacturing Practice is one of the indispensable elements of a modern control and authorization system in the field of pharmaceutical circulation, no less important than the Pharmacopoeia or other state drug standards. Materials and methods. The review article presents an analysis of published scientific works of the last 15 years. To search for reliable information, we used scientific literature data from available and open sources placed in scientific electronic databases: Cyberleninka, PubMed, E-library, Medline, J-stage, Hindawi using the keywords: Good Manufacturing Practice, GMP, pharmaceutical industry, quality of medicines. Results. When analyzing scientific literature sources, special attention is paid to the relevance of this problem, the prerequisites for the introduction of Good Manufacturing Practice standards in the pharmaceutical industry and world practice. Conclusion. Summarizing the scientific literature data, we came to the conclusion that it is necessary to comply with the basic requirements of the international Good Manufacturing Practice standard for the production of high-quality drugs, which has a positive effect on the health of consumers.
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Mahajan, Varun. "Structural changes and trade competitiveness in the Indian pharmaceutical industry in product patent regime." International Journal of Pharmaceutical and Healthcare Marketing 13, no. 1 (April 1, 2019): 21–39. http://dx.doi.org/10.1108/ijphm-12-2016-0066.
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Purpose This paper aims to present structural changes and trade competitiveness in Indian pharmaceutical industry in pre and post product patent regime. The study shows the impact of product patent on market structure, ownership, trade, revealed comparative advantage, R&D and mergers and acquisitions. Design/methodology/approach The study is based on secondary data and extensive relevant conceptual and empirical literature review. Findings The study finds that this oligopoly Indian dominant pharmaceutical industry has many challenges ahead such as in R&D expenditure, patent expiration of many major drugs manufactured in Ireland, growing competition in generic global market, bulk drugs dependence on China, rise in the number of M&As, rising costs of new drug discovery and tightening safety and efficacy testing requirements. The smaller firms are likely to act as the contract manufacturers for medium and bigger companies at a lower value chain. The Normalised Revealed Comparative Advantage (NRCA) index was calculated for top exporters of pharmaceutical. It was found that NRCA index of IPI has shown deterioration from 1996 to 2005 and thereafter, improvement except in the year 2009. Switzerland, Belgium and Ireland are the top three countries in NRCA index, which are followed by Germany, the UK and France. Originality/value It attempts to capture recent trends in market structure, comparative advantage indices, R&D, trade, M&A and ownership, especially in new IPR regime. There is a dearth of studies providing detailed analyses of India’s comparative advantage vis-a-vis other leading exporters of pharmaceutical products in the world. The paper would be of value to practitioners and scholars interested in structural changes of IPI, especially in product patent regime. The findings have significant implications for managers and government for future policymaking.
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Anton, V., K. Gehrke, and F. P. Hessel. "The Relevance of Health Services Research for the Pharmaceutical Industry in Germany –Results of A Representative Online Survey." Value in Health 17, no. 7 (November 2014): A414. http://dx.doi.org/10.1016/j.jval.2014.08.995.
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Weihrauch, Thomas R., and Eberhard Baumbauer. "ChemInform Abstract: Clinical Drug Research in Germany - Problems and Chances - From the Pharmaceutical Industry′s Point of View." ChemInform 30, no. 9 (June 17, 2010): no. http://dx.doi.org/10.1002/chin.199909283.
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Hering, Stefanie, Nico Schäuble, Thomas M. Buck, Brigitta Loretz, Thomas Rillmann, Frank Stieneker, and Claus-Michael Lehr. "Analysis and Optimization of Two Film-Coated Tablet Production Processes by Computer Simulation: A Case Study." Processes 9, no. 1 (December 30, 2020): 67. http://dx.doi.org/10.3390/pr9010067.
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Increasing regulatory demands are forcing the pharmaceutical industry to invest its available resources carefully. This is especially challenging for small- and middle-sized companies. Computer simulation software like FlexSim allows one to explore variations in production processes without the need to interrupt the running process. Here, we applied a discrete-event simulation to two approved film-coated tablet production processes. The simulations were performed with FlexSim (FlexSim Deutschland—Ingenieurbüro für Simulationsdienstleistung Ralf Gruber, Kirchlengern, Germany). Process visualization was done using Cmap Tools (Florida Institute for Human and Machine Cognition, Pensacola, FL, USA), and statistical analysis used MiniTab® (Minitab GmbH, Munich, Germany). The most critical elements identified during model building were the model logic, operating schedule, and processing times. These factors were graphically and statistically verified. To optimize the utilization of employees, three different shift systems were simulated, thereby revealing the advantages of two-shift and one-and-a-half-shift systems compared to a one-shift system. Without the need to interrupt any currently running production processes, we found that changing the shift system could save 50–53% of the campaign duration and 9–14% of the labor costs. In summary, we demonstrated that FlexSim, which is mainly used in logistics, can also be advantageously implemented for modeling and optimizing pharmaceutical production processes.
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Chase, D. P., and V. E. Amelung. "PHP25 The Pharmaceutical Industry as Partner in Integrated Care Contracts - Potential Improvement or Vain Attempt? First Experiences from Germany." Value in Health 15, no. 7 (November 2012): A293. http://dx.doi.org/10.1016/j.jval.2012.08.567.
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Tarasenko, V. A., T. V. Prykhodko, О. F. Кuchmistova, A. M. Solomenniy, O. V. Pleshkova, O. V. Belozerova, and D. V. Drozdov. "PHARMACEUTICALS MARKETING RESEARCHES FOR USE IN DERMATOLOGY AND ON THE PHARMACEUTICAL MARKET OF UKRAINE IN GENERAL (MESSAGE I)." Fitoterapia 3, no. 3 (2021): 67–74. http://dx.doi.org/10.33617/2522-9680-2021-3-67.
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Keywords: pharmaceutical, marketing research, medicinal product, marketing researches, active pharmaceutical ingredient, drug formulation, pharmaceutical market, wound process. The purpose of the study was to conduct complex marketing research of the current condition of the pharmaceutical market for use in dermatology to compose the well-balanced combination drugs (CD) for wound healing. Materials and methods: Conduct of complex marketing researches involved the use of general scientific, systematic, and survey research methods of informational search: bibliographical, document retrieval, content analysis, comparative approach, and system-oriented analysis. Results. The current condition of the domestic pharmaceuticals market was analysed and summed up for the availability of the Group D medicinal products according to Anatomical Therapeutic Chemical (АТС) classification system. Market dependency on import medicinal products was identified (import products share amounts to 57,8% of the market). The trends which reflect the innovation activity of the domestic pharmaceutical industry were presented in the findings. Prevailing (based on its specific density) medicinal products subgroups according to ATC classification «Corticosteroids for use in dermatology» (26,3%), «Anti-fungals for use in dermatology» (18,1%), «Antiseptics and Disinfectants» (14,1%), «Medicinal products for wound and ulcerous injuries healing» (12,7%), and «Antibiotics and chemotherapeutics» (11,5%). It was established that the main importers of the interested medicinal products groupare Germany (20,4%), India (16,2%), Poland (12,3%), Croatia (7,1%), Switzerland (6,3%), Belgium (5,2%), Austria (4,8%), and Hungary (4,2%). We found out that in the dermatology medicinal products segment, active pharmaceutical ingredients by their nature are mostly synthetic (88%), and by their composition, such medicinal products are mixed formulations with the subgroups market share between 58,5% – 76,3%. It was also shown that the optimal assortment range of modern combination drugs of dermatology medicinal products for 38 domestic producers is not yet reached. We paid attention to the perspective regarding the pharmaceutical development of new combination drugs for application therapy. Conclusions. The research of the effectiveness of different groups of medicinal products to wound healing on different stages, allowed us to conclude that the usage of imported combination effect medicinal products for wound healing is more cost-ineffective while the Ukrainian pharmaceutical market requires product differentiation and introduction of the new combined antimicrobial and anti- inflammatory effect medicinal products into production for wound healing and wound infection.
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Hollo, Anna-Lena. "Die Rolle des Staates bei der Entwicklung von Arzneimitteln und Impfstoffen." Die Verwaltung 54, no. 3 (July 1, 2021): 375–410. http://dx.doi.org/10.3790/verw.54.3.375.
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Pharmaceutical research in Germany has, so far, been financed almost exclusively by private companies. Hitherto, the research-based pharmaceutical industry is one of the few sectors that has managed without any noteworthy government research subsidies. Entrepreneurial commitment is still one of the decisive factors for progress in medicine. Direct state subsidies have just played a subordinate role in the past. The fact that the Federal Ministry of Research is supporting the development of vaccines against the SARS-CoV-2-virus with a total of 1.2 billion euros therefore appears even more extraordinary. But besides financial means, the German state is involved in many other ways in the development and approval of medicines and vaccines. The national legal requirements and regulations originate from the pen of the German legislators. At the same time, through various federal institutes and institutions, the German state is involved in the approval procedure, in the release process, in the distribution and in the monitoring of medicines and vaccines. However, the German government is not obliged to participate in the development of new medicines and vaccines in a certain way and to a certain extent. Rather, the type and scope are subject to its wide margin of appreciation which is only limited by the prohibition of insufficient actions. This leeway increasingly gets smaller, the more urgent, threatening and acute a health situation is for life and health of the citizens. In urgent cases as in a pandemic situation, the state’s duty to protect (Art. 2 § 2 Clause 1 of the German Basic Law) can then oblige the state to promote and to push the development of urgently needed medicines and vaccines, although the government remains free to choose the exact way how to fulfil this duty. It remains to be seen if, under the impact of the corona pandemic, the German government will continue to undertake greater (particularly financial) efforts to promote and push the development and the approval of new medicines and vaccines, or if this – what seems more likely – remains an exception for epidemic and pandemic situations.
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Stoll, Marlene, Lara Hubenschmid, Cora Koch, and Klaus Lieb. "Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016." BMJ Open 10, no. 9 (September 2020): e037395. http://dx.doi.org/10.1136/bmjopen-2020-037395.
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ObjectiveTo analyse voluntary payment reports of pharmaceutical companies to German healthcare professionals (HCPs) in 2015 and 2016 based on an industry-self-regulating transparency codex.Design and participantsCohort study of all German HCPs who voluntarily agreed that at least one payment they received in 2015 and 2016 from pharmaceutical companies is disclosed.Main outcome measuresNumber of HCPs who disclosed at least one payment in the database; separated by year of disclosure and whether they disclosed once or repeatedly. Amount of disclosed payments and distribution parameters of disclosed annual payment sums per person; separated by year of disclosure und whether they disclosed once or repeatedly.Results28 230 HCPs agreed to the disclosure of at least one payment in the database. In 2015, 19 905 HCPs agreed to the disclosure, decreasing to 15 782 HCPs in 2016. Whereas 7457 disclosed payments in both years, 12 448 disclosed only in 2015 and 8325 only in 2016. Payments of €32 426 721 in 2015 and €23 289 343 in 2016 were disclosed, that is, 27% and 23% of the total amounts spent on HCPs, respectively. Distribution of annual payments was skewed: the top 1% of HCPs disclosed annual payment sums between €17 049 and €200 194, while the median disclosed annual payment sum per person was €536 (IQR €1092). Disclosed payments were higher in male physicians and in physicians with higher academic degree.ConclusionsIf voluntary, disclosure rates of payments are low and therefore only provide a fragmented picture of interactions between HCPs and pharmaceutical companies. Efforts must be intensified to ensure obligatory disclosure of all payments worldwide.
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SCHÜTTE, TINO. "INVESTMENT ADJUSTMENTS IN PRODUCT MARKET COMPETITION." International Journal of Innovation and Technology Management 10, no. 05 (October 2013): 1340017. http://dx.doi.org/10.1142/s0219877013400178.
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Situated in the research field of market structure and strategic behavior, a model is developed, which shows the impacts of investment adjustments on product market competition. Placed in a multi-firm multi-product setting, the consequences of decisions to split budgets in: (i) marketing and development activities and (ii) development expenditures into innovative or imitative activities is investigated. The model is validated with empirical data of the pharmaceutical industry, especially the drug market in Germany. An agent-based modeling and simulation approach is used to explain how the freedom of firms to adjust their investment according to an absolute (individual aspiration level) or relative comparison (success of competitors) can change market performance. The results show that investment strategies adjusted to the behavior of direct competitors outperforms adjustments based on individual aspiration levels.
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Kashyntseva, Oksana, and Yaroslav Iolkin. "Ukrainian experience in implementation of the flexible provisions of the TRIPS Agreement in the context of European integration and the pandemic." Theory and Practice of Intellectual Property, no. 5 (November 17, 2021): 140–45. http://dx.doi.org/10.33731/52021.244533.
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Keywords: intellectual property, human rights, patients' rights, pharmaceutical nationalism,protectionism, vaccines, generics, COVID-19
The article concerns the analysis of global trends in theparadigm of intellectual property rights on the objects used in the diagnosis, preventionand treatment of COVID-19. The experience of the implementation of pharmaceuticalnationalism policies provided by the EU, Canada and Israel are presented in the article.The authors provide the legal backgrounds of the need for Ukraine to be a co-sponsor ofthe IP waivers proposals, which are submitted to the TRIPS Council by some membersof the WTO. The authors stress the need for Ukraine to use the historic opportunity forthe development of the national pharmaceutical industry, which would contribute tothe interests of the domestic patient, and make proposals for the necessary changes tonational legislation.The authors also stressed the position of the governments of Germany and France.Thus, in Germany there is the Law on Governmental Use of Patented Inventions duringa Pandemic. The law provides, inter alia, for amendments to the Patent Law, accordingto which the Federal Ministry of Health has the right to authorize the use of relevantpatents to ensure the production and supply of pharmaceuticals or medical devices.In 2020, France adopted the Emergency Law № 2020-290 to combat theCOVID-19 epidemic, which introduced Article 3131 15 of the French Public HealthCode. This rule authorizes the Prime Minister to issue orders to recover or seize allgoods and services necessary to combat the disaster, to temporarily control the price ofproducts and, if necessary, to take any measures to ensure that patients are providedwith appropriate drugs to deal with the disaster, related to health. It is useful forUkraine to use the experience of Canada in terms of facilitating negotiations with majorvaccine manufacturers to establish national drug production and in terms of developinglegislation in the field of compulsory licensing.It is obviously, voluntary licences from patent owners, which provide for the fulltransfer of technology, and not just patent disclosure, are the most effective tool for thenational production of biosimilars. However, international experience shows that pharmaceuticalcompanies are holding back the issuance of compulsory licences. Therefore,our government's biosecurity portfolio should include an effective tool for compulsory licensingor emergency use of biosimilars and generic drugs by the Government.
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Brittain, Harry G. "Book Review ofPolymorphism in the Pharmaceutical IndustryPolymorphism in the Pharmaceutical Industry . Edited by Rolf Hilfiker . Wiley-VCH Verlag GmbH & Co. Weinheim, Germany . 2006 . $215. 978-3-527-31146-0 ." Crystal Growth & Design 8, no. 7 (July 2008): 2588. http://dx.doi.org/10.1021/cg800538r.
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Lazorenko, Valeriia, Liudmyla Saher, and Adam Jasnikowski. "Web management as a marketing management determinant: case for pharmaceutical enterprises." Health Economics and Management Review 2, no. 2 (2021): 105–14. http://dx.doi.org/10.21272/hem.2021.2-10.
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Nowadays, the online business is fast-growing since it is convenient, more profitable, and less energy-consuming. The changing consumers’ needs force companies and organizations to adjust and modernize their marketing strategies. The authors emphasized that Internet advertising channels would overcome the traditional ones. Therefore, it is relevant to consider the latest trends in e-commerce to provide effective advertising campaigns. This study aims to conduct the competitive analysis of Ukrainian veterinary enterprises’ websites as one of the key marketing management determinants. The study object are the most prominent Ukrainian veterinary enterprises. The methodological basis for this paper includes trend, bibliometric, and comparative content analysis. The trend analysis results showed a constant interest in web management worldwide. In turn, there are significant fluctuations over the previous five years in Ukraine. The findings indicated that search requests for «pharmaceutics» worldwide are gradually increasing, while there is not enough statistic data in Ukraine. The bibliometric analysis for Scopus publications addressed the marketing management in the pharmaceutical were visualized by 4 clusters. The first cluster covers marketing, management, and risk issues; the second – pharmaceutical industry, the third – economy; and the fourth – quality control. The findings showed that veterinary medicine was mostly associated with drug efficacy, management, investment, management, risk, organization and management, patents, and quality control. This issue has been most actively studied by scientists from the United States, Britain, Germany, India, and Italy. This study provided the comparative analysis of veterinary enterprises web sites based on the main indicators as follows: usability, site structure, site indexation, number of external pages, overall traffic, behavioral factors (bounce rate, pages per visit, time on site), traffic sources (direct, referrals, SEO, SMM, e-mail, and display advertising), and adaptability to the mobile versions. The obtained results showed that all Ukrainian biological vaccines manufacturers for animals were represented on the Internet. In turn, as of September 2020, Biotestlab most effectively used the Internet to promote products. In second place is the Sumy Biological Factory, and then – Kherson Biological Factory.
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Kaffai, Marius, and Raphael H. Heiberger. "Modeling non-pharmaceutical interventions in the COVID-19 pandemic with survey-based simulations." PLOS ONE 16, no. 10 (October 28, 2021): e0259108. http://dx.doi.org/10.1371/journal.pone.0259108.
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Governments around the globe use non-pharmaceutical interventions (NPIs) to curb the spread of coronavirus disease 2019 (COVID-19) cases. Making decisions under uncertainty, they all face the same temporal paradox: estimating the impact of NPIs before they have been implemented. Due to the limited variance of empirical cases, researchers could so far not disentangle effects of individual NPIs or their impact on different demographic groups. In this paper, we utilize large-scale agent-based simulations in combination with Susceptible-Exposed-Infectious-Recovered (SEIR) models to investigate the spread of COVID-19 for some of the most affected federal states in Germany. In contrast to other studies, we sample agents from a representative survey. Including more realistic demographic attributes that influence agents’ behavior yields accurate predictions of COVID-19 transmissions and allows us to investigate counterfactual what-if scenarios. Results show that quarantining infected people and exploiting industry-specific home office capacities are the most effective NPIs. Disentangling education-related NPIs reveals that each considered institution (kindergarten, school, university) has rather small effects on its own, yet, that combined openings would result in large increases in COVID-19 cases. Representative survey-characteristics of agents also allow us to estimate NPIs’ effects on different age groups. For instance, re-opening schools would cause comparatively few infections among the risk-group of people older than 60 years.
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Dintsios, C., and S. Schlenkrich. "Pharmaceutical Industry\X92S Experiences With The Scientific Advice Offered By The Federal Joint Committee Within The Early Benefit Assessment Of Drugs In Germany." Value in Health 19, no. 7 (November 2016): A450. http://dx.doi.org/10.1016/j.jval.2016.09.598.
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Bechoux, Lucas, Oriane De Vleeschouwer, Cécile Vanheuverzwijn, Florence Verhegghen, Alizée Detiffe, Fabian Colle, Catherine Fallon, and François Thoreau. "Conflict of interest policies at Belgian medical faculties: Cross-sectional study indicates little oversight." PLOS ONE 16, no. 2 (February 10, 2021): e0245736. http://dx.doi.org/10.1371/journal.pone.0245736.
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Background Medical students encounter pharmaceutical promotion from the very start of their training. Medical schools have an important role to play in educating medical students regarding the interactions between healthcare professionals (HCPs) and industry and in protecting them from commercial influence and conflict of interest (COI). In 2019, medical student associations in Belgium and abroad called for more preparation in dealing with COI and for a more independent medical training. As little information is available on the situation in our country, we undertook an assessment of conflict of interest policies at Belgium’s medical schools. We relied on a methodology already used in studies from USA, Canada, Australia, France and Germany and adapted it to the Belgian context. Methods We identified 10 medical schools in Belgium. We searched the website of each medical school in November 2019 with standardized keywords for COI policies and learning activities on COI in the curriculum. The deans of medicine were invited to participate by sending us information that we could have overlooked during our web-based searches. We also consulted personal contacts within faculties among students and teachers. Based on a list of 15 criteria adapted from North American and French studies, we calculated a total for each faculty of medicine with a maximum score of 30 points. Results By December 2019, we had gathered a set of written documents for four faculties of medicine (40%) containing policies with varying degrees of precision and relevance to our survey. We found elements of the curriculum addressing the COI issue for one faculty (10%). In all cases, these policies consisted of “moderate” initiatives with little or no “restrictive” elements. Only one faculty showed interest in our study by providing us with relevant information (10%). Half of the faculty notified us of their refusal to participate in the study (50%) and the other faculties either did not respond or did not provide us with any information (40%). The maximum score obtained was 3 out of 30 points with six faculties scoring 0 (60%). Conclusion There is little transparency regarding interactions between medical students and pharmaceutical companies at Belgian medical faculties, which may create COI issues. Initiatives to protect students from pharmaceutical promotion and to train them to manage their future interaction with pharmaceutical companies have a limited scope and are isolated. This is inconsistent with international recommendations from Health Action International, World Health Organization or the American Medical Students’ Association. The Belgian government has legislated in favor of more transparency in the relation between HCPs and pharmaceutical industry. Indeed, it made the disclosure of benefits granted by the industry compulsory and limited their value. Our results show that there is still some way to go to ensure an independent medical training for future Belgian physicians.
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Götze, Stefanie, Debora Jeske, and Karolina Benters. "Training challenges in regulated industries: making it work." Strategic HR Review 17, no. 3 (June 11, 2018): 155–59. http://dx.doi.org/10.1108/shr-12-2017-0089.
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Purpose Trainers and organisations in heavily regulated industries face a number of training-related HR challenges. The purpose of this paper is to examine barriers and propose solutions in such circumstances. Design/methodology/approach The paper briefly outlines the results of a case study involving multi-method data collection (interview, survey, focus groups, etc.) to explore barriers to training effectiveness in a pharmaceutical company in Germany. Findings The case study suggests that the company in question experienced several time and resource pressures to accommodate internally and externally required training needs. Other issues pertained to negative effects of these circumstances on employee motivation, engagement and relevance of training. Practical implications Based on the case study and existing work, a number of general practical recommendations are outlined for trainers working in regulated industries. These include suggestions such as the need for situation awareness in the design of the training strategy, co-creation in training, the benefit of linking training to reward systems, training accreditation and the benefit of reviewing existing training approaches in the regulated industry. Originality/value The paper provides one starting point for those leading and managing training activities in regulated industry settings to manage the internal and external training challenges.
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Schreuder, Y. "The German-American Pharmaceutical Business Establishment in the New York Metropolitan Region." Environment and Planning A: Economy and Space 30, no. 10 (October 1998): 1743–56. http://dx.doi.org/10.1068/a301743.
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Between World War 1 and World War 2, the New York metropolitan region became the main region for the production of organic synthetic pharmaceuticals in the United States. The leaders in this area of specialization were subsidiaries of foreign—mostly German—companies which had established distribution networks in the 19th century and had begun manufacturing pharmaceuticals in the region at the turn of the century. By looking back to the mid-19th century, the author analyzes the relationships between the German professional and business immigrant community in New York (among them the Forty-Eighters), the development of the New York hinterland, and the success of the German-American pharmaceutical business establishment, in an effort to discern one possible explanation of the concentration of the pharmaceutical industry in New York metropolitan region.
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Eandi, Mario, and Carlo Della Pepa. "I farmaci “generici” in Italia: opportunità di ricerca e sviluppo di prodotti di qualità a prezzi competitivi." Farmeconomia. Health economics and therapeutic pathways 4, no. 2 (June 15, 2003): 65–76. http://dx.doi.org/10.7175/fe.v4i2.770.
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Every drug whose copyright coverage has expired can be manufactured by a pharmaceutical company other than the one that developed it, giving rise to the market of the so-called generic drugs. It can be distinguished among two types of generic drugs: branded and unbranded, according to the choice of the manufacturer to assign it a fantasy name or to sell it with the name of the active principle, followed by the company’s name. In order to be accepted for marketing, every new drug has to pass the registration procedures of the Italian Ministry of Health, which are simplified for generics, as it’s sufficient to demonstrate the bioequivalence, considered a reliable proxy of therapeutic equivalence, of the new drug with the standard formulations it copies. The bioequivalence of two drugs depends on various parameters, related to the quality of the raw materials employed and the industrial processes they go through. There are several ways of assessing the equivalence between pharmaceutical products, and it is important the registration studies are conducted following strict rules, in order to guarantee the quality of generics, fundamental for achieving the trust of health operators and patients. The reason to be of generic drugs is essentially economic, as they bare no therapeutic innovation, and their introduction is mainly aimed to contain drug expenditures and to facilitate a competitive market, but to do so, they need to be widely accepted by the medical community and the population. In Italy, the market of generic drugs is very young and relatively underdeveloped if compared to what is observed in other industrialized countries such as the USA, Germany or UK, but it has a good expansion potential, as it also represents a chance for quality enhancement for the Italian pharmaceutical industry.
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Mohammad, Al Sayasneh, O. A. Ruban, I. V. Kovalevska, and O. M. Ievtushenko. "Аnalysis of the market of medicinal products for the conservative treatment of hemorrhoids in order to determine the marketing opportunities for a domestic manufacturer." Social Pharmacy in Health Care 8, no. 4 (December 19, 2022): 46–58. http://dx.doi.org/10.24959/sphhcj.22.274.
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The spread of diseases of the rectum, namely hemorrhoids, leads to the deterioration of the physical and psychological health of the working-age population, increases the budget costs of the healthcare system, insurance companies, and the population’s own funds. In this regard, the development of new complex medicinal products is always relevant for domestic pharmacy.
Aim. To form a modern idea of the market structure and trends in the consumption of drugs for the conservative treatment of hemorrhoids, determine the possible potential for domestic developers and manufacturers.
Materials and methods. The research was conducted using the structural analysis logical and graphic methods, methods of marketing analysis.
Results. It was found that recently the market of antihemoroidal agents for topical application and capillary-stabilizing agents developed quite vigorously – the market growth rates in the period of 2020-2021 were from 15 to 23 % in physical units and from 28 to 40 % in monetary units. However, according to the structure of the producing countries, the market remains import-dependent. Drugs from France, Switzerland, Bulgaria, Germany, Spain, Slovenia, Italy, and the United States are available on the market. The leaders of sales are products manufactured by Servier (France), Innotek International (France), and Teva (Israel). The leaders in the supply of domestic drugs of this group are Borshchagovsky Chemical Pharmaceutical Plant, JSC “Galichpharm”, Kyiv Vitamin Plant, PJSC “Darnitsa” Pharmaceutical company”, PJSC “Monpharm”. The most popular dosage forms are tablets, capsules, gels, ointments, suppositories.
Conclusions. Based on the changes identified, certain proposals have been developed for the domestic pharmaceutical industry – the market has a relatively small range of domestic complex medicines combining components of chemical and natural origin, including the plant raw material. The market has a positive development trend; therefore, further search for an effective complex drug is expedient.
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Kang, Moon Young. "What Makes Companies to Survive over a Century? The Case of Dongwha Pharmaceutical in the Republic of Korea." Sustainability 14, no. 2 (January 14, 2022): 946. http://dx.doi.org/10.3390/su14020946.
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Considering their significant impacts on national economy, local communities, employees, suppliers, and other stakeholders, firm survival is an important goal for most companies. However, firm longevity is not an easy result to achieve, and it becomes more difficult as business environments shift dramatically. The average life span of companies listed in Standard and Poor’s 500 was 61 years in 1958, but it fell to less than 18 years in 2016. Nevertheless, more than 3000 companies over 200 years old still operate in Japan, mostly family inherited small and medium enterprises (SMEs), and Germany has many centenarian companies, especially in the manufacturing industry. However, in the Republic of Korea, with over 4000 years of history, there are no companies older than 200 years and only seven companies with over 100 years of history. Centenarian companies in Korea are very limited, and even after surviving over 100 years, they continue to face severe challenges they need to overcome in order to survive. However, it is not clearly proven what factors affect the survival of companies for over a century. Since SMEs contribute to the economic development and survival of a country, it is important to investigate the secrets of their longevity, which has become even more difficult than ever. However, as there is very limited research on firm longevity, the findings from this case study of Dongwha Pharmaceutical, balancing the continuity of tradition and innovation, provide significant implications and practical guidelines for Korean SMEs for their survival and sustainable management, which is an economic and business aspect of sustainability.
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Cornago, Dante, and Livio Garattini. "Il mercato dei dispositivi per stomia in cinque paesi europei: lezioni per l’Italia." Farmeconomia. Health economics and therapeutic pathways 2, no. 2 (June 15, 2001): 115–23. http://dx.doi.org/10.7175/fe.v2i2.724.
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Aim of the present study is to analyze the international market of the ostomy devices in Italy, France, Germany, U.K. and Denmark. The ostomy systems are technologically mature devices, and the more interesting market developments are about innovative modality of distribution and patients technical support, like home distribution. For every country it has been applied a common pattern, based on four aspect of the ostomy devices market: 1. the legislative aspect; 2. the prescription procedure; 3. the different models of distribution; 4. the competitive systems of pharmaceutical industry. All the data in this study has been galthered through relevant literature and interviews with the area operators. The ostomy devices are repayable against medical prescription in all the studied countries; significant legislative differences are registered in the repayment prices determination. For all the studied countries, in the decisional process related to the choice of one or another device, the essential role is played by the ostomy hospital nurse, that advises the patient immediately after the surgery. Finally, the more significant examples to innovate purchase and distribution process of ostomy devices in Italy comes from Denmark and U.K., where the home distribution is already available and it is working.
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Farahani, I., A. Laven, S. Farahani, MA Deters, M. Feickert, FK Suessenbach, H. Schwender, and S. Laeer. "P33 Effectiveness of OSCEs in training German pharmacy students in consultation on self-medication – a randomised controlled investigation." Archives of Disease in Childhood 104, no. 6 (May 17, 2019): e30.2-e31. http://dx.doi.org/10.1136/archdischild-2019-esdppp.71.
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BackgroundIn Germany 37.1% of dispensed medicinal products were intended to use in self-medication in 2017.1 An investigation showed that 25.2% of children and adolescents used self-medication in Germany.2 Hence, pharmacists’ education needs to include training for competence in consultation.3A modern method to train this competence is the use of OSCEs (Objective Structured Clinical Examinations). The aim of this study was to assess whether the use of OSCEs in pharmacy students to train the consultation performance on self-medication is more effective than a conservative teaching method.MethodsThis randomised controlled investigation was conducted in a pre-post-design with pre-OSCEs before training and post-OSCEs after training in each group. Clinical skills at baseline and after the training were measured. Forty students in their last year of pharmacy studies were randomised into a control and an intervention group. The control group attended a lecture on self-medication and the intervention group had additionally to the lecture one hour of OSCEs for training purpose. An analytical checklist was used for measuring consultation skills and a global rating scale for assessing communication skills.ResultsComplete data was received from 30 students (n=16 intervention group, n=14 control group). Consultation skills improved significantly (analytical checklist: 19.88% ± 10.95% intervention group vs. 9.29% ± 10.89% control group, p< 0.05). However, the communication skills (global rating scale: 20.83% ± 24.33% in the intervention group vs. 11.90% ± 17.12% in the control group, p= 0.380) did not improve significantly during the one-hour training period.ConclusionOSCEs for training purpose are an effective method to convey pharmacy students consultation skills in self-medication. However, communication skills need more training. Based on these results OSCEs on self-medication for the paediatric population should be investigated. This is relevant due to the frequency of self-medication in the paediatric population.ReferencesAbda.de. [Internet]. Berlin: Federal union of German associations of pharmacists. Numbers, data, facts 2016. [Cited January 30, 2019]. Available from: https://www.abda.de/fileadmin/assets/ZDF/ZDF_2018/ABDA_ZDF_2018_Brosch.pdf Du Y, Knopf H. Self-medication among children and adolescents in Germany: results of the National Health Survey for children and adolescents (KiGGS). Br J Clin Pharmacol 2009;68:599–608.Joint Statement by the International Pharmaceutical Federation (FIP) and the World Self Medication Industry (WSMI). [Internet]. Responsible Self-medication. 1998. [Cited January 30, 2019]. Available from: https://www.fip.org/www/uploads/database_file.php?id=241&table_id=.Disclosure(s)Imaneh Farahani, Anna Laven, Samieh Farahani, Maira A. Deters, Martin Feickert, Fabian K. Suessenbach, Holger Schwender and Stephanie Laeer declare that they have no conflict of interest.
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Uliasz-Misiak, Barbara. "Water Accompanying Hydrocarbon Deposits as a Potential Source of Iodine, Lithium and Strontium." Gospodarka Surowcami Mineralnymi 32, no. 2 (June 1, 2016): 31–44. http://dx.doi.org/10.1515/gospo-2016-0012.
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Abstract Oil and natural gas fields are accompanied by formation waters, usually highly mineralized brines containing a variety of trace elements. Analyses carried out in various sedimentary basins around the world indicate that these waters are often enriched in elements such as iodine, lithium and strontium. Currently, these micronutrients are finding increasing application in the production of lithium-ion batteries and lithium batteries (lithium) and in the pharmaceutical, medical and pharmaceutical industry (iodine). Due to the development of production of LCD displays and batteries (e.g. for electric cars), the expected increase in demand for iodine and lithium is 2% and 1.5%, respectively. The reserves of these elements are limited and unevenly distributed. Iodine is currently produced in the three countries: Chile (65% of the world production), Japan and the US. Lithium is produced in Argentina, Australia and Chile, while strontium is produced in China (50% of the global production), Spain and Mexico. Iodine, lithium and strontium are not produced in Poland and the total demand is met by imports. Brines with high iodine content, occurring in the hydrocarbon deposits, have been found in oil basins in the United States, Canada and Germany. In the United States, this element is recovered from formation water. Lithium found in numerous formation waters in the US, Canada, Japan and Germany has not yet been recovered, while the construction of the pilot plant in Canada is underway. The increased strontium content has been found in waters accompanying hydrocarbon deposits in North America and China. However, strontium has not yet been recovered from the aforementioned deposits. In Poland, the question of possible use of chemical elements dissolved in reservoir brines, with the exception of iodine, has not yet been studied. The above mentioned element (iodine) was recovered from brines in the area of Bochnia (Carpathian Foredeep), the only geological unit where an analysis of iodine content in the formation waters has been carried out in the recent years. The lithium and strontium content in the formation waters, as well as the question of their possible use, have not yet been studied.
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Krstić, Đurđa, Petar Ristivojević, Filip Andrić, Dušanka Milojković-Opsenica, and Gertrud E. Morlock. "Quality Assessment of Apple and Grape Juices from Serbian and German Markets by Planar Chromatography—Chemometrics." Molecules 27, no. 12 (June 19, 2022): 3933. http://dx.doi.org/10.3390/molecules27123933.
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The high consumption of plant-based foods on a global scale has increased the number of adulterations in the food industry. Along with this, analytical approaches to fraud detection need to be further developed. A nontargeted effect-directed profiling by high-performance thin-layer chromatography hyphenated with five effect-directed assays (free radical scavenging assay, Aliivibrio fischeri bioassay, and acetylcholinesterase, butyrylcholinesterase, and tyrosinase inhibition assays) and multi-imaging provided additional information on the antioxidative, antimicrobial, and enzyme inhibition activities for 18 apple and 18 grape juices from markets in Serbia and Germany. Bioactive zones of interest were eluted using an elution head-based interface and further characterized by electrospray ionization high-resolution mass spectrometry. The different profiles were evaluated chemometrically, and several compounds, which were characteristic of samples from different markets located in Serbia and Germany, were identified in apple juice (such as chlorogenic acid, phloridzin, epicatechin, and caffeic acid) and grape juice (such as chlorogenic acid, epicatechin, and quercetin). The developed rapid and simple method for the quality assessment of fruit juices coming from different (geographic) markets showed clear quality differences. Thus, it could be used to learn more about quality differences, to detect fraud in fruit juice production, and to verify the authenticity of the origin.
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Geraats, B., M. Parnowska, and L. Kox. "Future proof decentralised sludge recycling Elodry-pro®." Water Practice and Technology 15, no. 3 (December 8, 2016): 840–48. http://dx.doi.org/10.2166/wpt.2017.018.
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Abstract At Linz-Unkel (Germany) sewage treatment plant the first full scale state-of-art EloDry-Pro® plant for sewage sludge has been constructed, consisting of the PYREG® reactor and the EloDry® belt dryer. The system is characterised by small footprint, flexibility, modular design and efficient energy management. The sludge dried using an EloDry® belt dryer undergoes staged combustion using the PYREG® module at around 6,500°C. This reduces the sludge to a fraction of its original volume while disinfecting it and removing micro-pollutants such as pharmaceutical residues. The residual ash, which has a high percentage of plant-available phosphorus, is then supplied to the fertiliser industry as a recycled raw material. The working principle of EloDry-Pro® installation, including heat flows of the system, is presented. The paper describes Pyreg®'s advanced emission control systems, preventing NOx formation and removing harmful substances such as mercury and sulphur. The EloDry-Pro® technology is an innovative and cost-effective approach to decentralised thermal recycling of sewage sludge. Both sewage sludge volumes and transportation costs are reduced by up to 90%, therefore making it a low carbon cost-effective alternative to the transportation of sludge and allowing local sludge processing at plants under 100 k population.
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Monleon, Clara, Mondher Toumi, Hans-Martin Späth, Claude Dussart, and Carlos Crespo. "PP114 The Influence Of Implicit Factors On The Health Technology Assessment Deliberative Process: A Survey In Five European Countries." International Journal of Technology Assessment in Health Care 38, S1 (December 2022): S78. http://dx.doi.org/10.1017/s0266462322002379.
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IntroductionImplicit factors can be defined as any criteria that play a role in the health technology assessment (HTA) deliberative process but are not part of the HTA framework. To date, very few studies have explored the influence of implicit factors on this process. This survey of HTA experts in five European countries aimed to analyze the influence of implicit factors on the HTA deliberative process.MethodsSemi-structured interviews with 20 HTA experts from five European countries (France, Germany, Italy, Spain, and the United Kingdom) were conducted from February to May 2021. The main topics of the interviews were: the HTA deliberative process; the degree of influence on the HTA deliberative process of a set of factors previously identified in a systematic literature review performed by the authors; and recommendations for improving the deliberative process.ResultsAll but two of the experts concurred that implicit factors played a role in the deliberative process. German experts considered that the factors explored had a low influence on the process. Burden of disease and unmet need scored highest, followed by the professional experience of the people involved in the HTA deliberative process. To improve the deliberative process, experts suggested expanding the external stakeholder perspective (i.e., including patients, the pharmaceutical industry, and the public), increasing transparency when revealing implicit factors, and implementing a methodology to mitigate the influence of implicit factors.ConclusionsOur survey indicates a need to increase external involvement in the process and to develop a methodology for unmasking the implicit factors in the deliberative process. This may be achieved by either updating the current frameworks to include these implicit factors or by developing new methods to address them. Further research may explore approaches to acknowledge the implicit factors in the HTA deliberative process in a systematic manner.
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Blackett, Tom. "Branding and the Rise of the Generic Drug." Marketing Intelligence & Planning 10, no. 9 (September 1, 1992): 21–24. http://dx.doi.org/10.1108/02634509210020097.
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Attempts to describe some of the forces which, from a marketing perspective, drive and shape the pharmaceutical industry. The industry is of massive importance to the UK economy and rarely a day goes by without mention in the press of the activities of the leading manufacturers – Glaxo, Wellcome, SmithKline Beecham etc. British companies are amongst the most innovative in the world and pharmaceuticals is the only area of science where the UK can claim to match, and frequently outperform, the Americans, Japanese and Germans. Written by a layman for the benefit of laymen.
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Kuhach, V. V. "PHARMACY MANUFACTURE AND QUALITY CONTROL OF MEDICINAL PREPARATIONS ABROAD." Vestnik Farmacii 92, no. 2 (June 30, 2021): 64–79. http://dx.doi.org/10.52540/2074-9457.2021.2.64.
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The purpose of this work was to study foreign experience in pharmacy manufacture and quality control of medicinal preparations (MP). Scientific literature and internet sources analysis, the author's own observations from 2005 to 2020 were made. It has been established that pharmacy manufacture of MPs abroad is carried out for the special needs of patients when pharmaceutical industry cannot produce them for various reasons. There are various approaches to standardization of the number of manufacturing pharmacies abroad: from complete prohibition of pharmacy manufacture of medicinal preparations in Portugal to mandatory license requirement in Austria and Germany. To manufacture medicinal preparations at a pharmacy the laboratory is established where necessary equipment, inventory, pharmaceutical substances and excipients are placed and the technological process is carried out. Pharmacy manufacture of sterile medicinal preparations is conducted under aseptic conditions in a specially equipped room or in a laminar-airflow cabinet. MPs must not be registered in most countries of the world. In the US and the European Union (EU) medicinal preparations are classified into medicines for immediate use and for prolonged storage. Expiration date must be stated for prolonged storage medicinal preparations, a dossier is made for them in the EU pharmacies. Pharmacies in most countries of the world manufacture medicinal preparations from tablets and capsules. Much attention abroad is given to ensure the quality of pharmacy manufacture of medicinal preparations: in the US, pharmacy manufacture of medicinal preparations is carried out in accordance with the requirements of Pharmacopoeia, in the EU according to the EU Council Resolution. A number of countries have developed guidelines or standard operational procedures for pharmacy manufacture of medicinal preparations. Constant training and assessment of employees’ competencies engaged in pharmacy manufacture of medicinal preparations is performed.
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Yoshimori, Masaru. "The German Healthcare System and Pharmaceutical Industry." Iryo To Shakai 12, no. 2 (2002): 21–48. http://dx.doi.org/10.4091/iken1991.12.2_21.
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Andryushayev, Oleksiy, Olena Ruban, Yuliia Maslii, and Inna Rusak. "Intensification of the extraction process of phenolic compounds from Acorus calamus leaves." ScienceRise: Pharmaceutical Science, no. 4(32) (August 31, 2021): 4–10. http://dx.doi.org/10.15587/2519-4852.2021.238329.
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The aim. To determine the intensified method of extraction of phenolic compounds from Acorus calamus leaves and optimal conditions for the process.
Materials and methods. In order to develop the optimal intensified method of extraction samples were prepared in different conditions of raw materials-extractant ratio, temperature, time and multiplicity. As a raw materials spectrophotometrically pre-standardized Acorus calamus leaves were used. The extraction was carried out in a hermetically sealed ultrasonic extraction reactor PEX 1 (REUS, Contes, France). As the criteria of extraction efficiency were indicators of dry residue and total amount of flavonoids determined using methods described in State Pharmacopoeia of Ukraine. The amount of flavonoids was determined spectrophotometrically on a certified device Specord 200 (Analytik Jena, Germany).
Results. According to our research results it was found that ultrasonic action and addition of surfactant significantly improves the efficiency of the extraction process. The optimal conditions for the process were determined. Experimentally proved that the rational raw material-extractant ratio is 1:15. Comparative study of the extraction process with different temperatures showed that the highest amount of extractives is achieved at temperature 70 °C and 45 min of duration. The optimal extraction multiplicity is 3.
Conclusions. As a result of the study, the intensified extraction method for Acorus calamus leaves – re-maceration with ultrasound – was established. The conducted researches allowed to develop the method of extraction, expedient in the conditions of the modern pharmaceutical industry.
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BENNETT, G. "Peter Bamfield, Research and Development in the Chemical and Pharmaceutical Industry (3rd ed.), Wiley–VCH Verlag GmbH & Co., Weinheim, Germany (2006) 288 pp., Price: US$ 100.00, ISBN: 3-527-31775-9." Journal of Hazardous Materials 145, no. 3 (July 16, 2007): 521. http://dx.doi.org/10.1016/j.jhazmat.2007.02.065.
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