Relevant bibliographies by topics / The production of medicines

Academic literature on the topic 'The production of medicines'

Author: Grafiati
Published: 10 March 2023

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Journal articles on the topic "The production of medicines"

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Beregovykh, V. V., and O. R. Spitskii. "TECHNOLOGY TRANSFER TO THE FACILITY FOR PRODUCTION OF MEDICINES." Annals of the Russian academy of medical sciences 68, no. 12 (December 10, 2013): 49–57. http://dx.doi.org/10.15690/vramn.v68i12.860.

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Innovation development of pharmaceutical industry is close connected to knowledge transfer going to each subsequent life cycle phase of medicinal product. Formal regulation of technology and knowledge transfer is essential for achievement high quality during production of medicines designed during development phase. Conceptual tools, approaches and requirements are considered that are necessary for knowledge and technology transfer across all the life cycle phases of medicines. They are based on scientific knowledge of medicinal products and take into account both international and Russian regulations in the area of development, production and distribution of medicines. Importance of taking into consideration all aspects related to quality of medicines in all steps of technology transfer is shown. An approach is described for technology transfer organization for Russian pharmaceutical manufacturers based on international guides in this area.
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Li, Zhiyong, Caifeng Li, Xiaobo Zhang, Shihuan Tang, Hongjun Yang, Xiuming Cui, and Luqi Huang. "Policies and Problems of Modernizing Ethnomedicine in China: A Focus on the Yi and Dai Traditional Medicines of Yunnan Province." Evidence-Based Complementary and Alternative Medicine 2020 (August 14, 2020): 1–14. http://dx.doi.org/10.1155/2020/1023297.

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Yunnan is a multiethnic province in southwest China, rich in Materia medica resources, and is popularly known as the kingdom of plants. Biomedicine and public health industry have been the industrial pillars of Yunnan since 2016, which is the important pharmaceutical industrial base for Dai and Yi medicine in China. This review of the Yunnan ethnic medicine industry describes some of the problems to be solved in the development of sustainable ethnomedicine in China. We investigated Chinese patent medicines (CPMs) declared as ethnomedicine on the drug instructions and identified 28 Dai patent medicines (DPMs) and 73 Yi patent medicines (YPMs) that were approved for clinical use in China. In further research, the clinical indications of these CPMs were determined, and the quality standard of medicinal materials and their usage frequencies in DPMs and YPMs were investigated. We also collected and analyzed the data on use of botanical and animal sources of medicines, the rare and endangered medicinal materials, and toxic medicines in DPMs and YPMs. The application of zootherapy in Yi traditional medicine was introduced from its abundant ancient documents and records; based on the “YaGei” theory in Dai traditional medicine, toxic medicines can be relatively safe in DPMs. However, for promoting the Yunnan traditional medicine industry, it is necessary to strengthen medical research to expand evidence-based clinical practice and balance ethnomedicine production and sustainable utilization of Materia medica resources, especially the animal sources of medicines, toxic medicines, and the protected wild resources reported in this survey. Only in this way can industrialization of ethnomedicine promote the improvement of human health.
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Sheikhmambetova, L. N., E. A. Egorova, E. Yu Bekirova, and K. N. Onishchenko. "MARKETING STUDY OF ORAL FORMS OF OMEPRAZOLE PREPARATIONS USED FOR THE TREATMENT AND PREVENTION OF GASTROESOPHAGEAL REFLUX DISEASE AND GASTRIC ULCER." Modern organization of drug supply 8, no. 2 (June 15, 2021): 28–37. http://dx.doi.org/10.30809/solo.2.2021.3.

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Some of the most widespread illnesses of alimentary canal are the stomach (gastric) ulcer, duodenal ulcer disease, gastroesophageal reflux diseases. The ethanol of antisecretory treatment of the given acid-dependent diseases are the preparations of the proton pump inhibitor group with omeprazole which is considered to be more effective and investigated. The goal of the research is the oral medications omeprazole (20 mg) assortment market investigation. Materials and methods. The research objects are the State register of medicines data of oral medicinal products including omeprazole dosing 20 mg recorded on the pharmaceutical market as well as the State price register data on the vital medicinal products on April, 4, 2021. Results. According to the SRMP 30 trade names of medicinal products including omeprazole dosing 20 mg as active ingredient in capsules and tablets are registered on the pharmaceutical market in Russian Federation. The omeprazole products distribution in the countries holding registration certificates showed the predominance of domestic production medicinal products (18 trade names, 60 %). The cost analysis of standard daily and course dose oral omeprazole form (20 mg) of different trade names allowed to select economically profitable preparations (”Omeprazole”, LLC “Production of Medicines”, Russia; “Omeprazole”, OJSC ‘‘Synthesis”, Russia; “Omeprazole” LLC BFMP, Russia), the insert of which into the list of medicines to provide the gastroesophageal reflux disease and stomach (gastric) ulcer patients at the regional level is economically feasible as well the medicines with the high price (Losec MUPS AstraZeneca AB, Sweden). Сonclusion. The results of the pharmaceutical market research of oral omeprazole form (20mg) indicates a great majority of generic medicine, a sufficient market capacity, medicine predominance of domestic production (60%).
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Camargo, Ely Eduardo Saranz, Mary Anne Medeiros Bandeira, and Anselmo Gomes de Oliveira. "Diagnosis of Public Programs focused on Herbal Medicines in Brazil." Natural Product Communications 6, no. 7 (July 2011): 1934578X1100600. http://dx.doi.org/10.1177/1934578x1100600720.

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The present study is aimed to diagnose the current public programs focused on herbal medicines in Brazil by means of in loco visits to 10 programs selected by means of questionnaires sent to 124 municipalities that count on herbal medicine services. The main purpose of the implementation of program programs is related to the development of medicinal herbs. 70% of them are intended for the production of herbal medicines and 50% are aimed to ensure the access of the population to medicinal plants and or herbal medicines. The initiative of the implementation of these programs was related to the managers (60%). The difficulties in this implementation were due to the lack of funding (100%) of the programs. In 60% of the programs, the physicians did not adhere to herbal medicine services due to the lack of knowledge of the subject. Training courses were proposed (80%) to increase the adhesion of prescribers to the system. Some municipalities use information obtained from patients to assess the therapeutic efficiency of medicinal plants and herbal medicines. Of the programs underway, cultivation of medicinal plants was observed in 90% and 78% of them adopt quality control. In most programs, this control is not performed in accordance with the legal requirements. The programs focused on medicinal plants and herbal medicines implemented in Brazil face some chronic problems of infrastructure, management, operational capacity and self-sustainability, which can be directly related to the absence of a national policy on medicinal plants and herbal medicines.
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Rathod, Rucha, and Raman R. Chandak. "Review on “Standardization an Imp Tool for Herbal Drug Development”." Journal of Drug Delivery and Therapeutics 9, no. 6-s (December 15, 2019): 253–57. http://dx.doi.org/10.22270/jddt.v9i6-s.3784.

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The medicinal plants are important source for pharmaceutical manufacturing. Medicinal plants & herbal medicines account for a significant percentage of the pharmaceutical market. There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice although most of these applications are not scientific. Herbal medicines are not a simple task since many factors influence the biological efficacy and Reproducible therapeutic effect. So it is necessary to improve safety of herbal drugs by developing certain quality control parameters & by following the WHO guidelines for herbal medicines. This review seeks to enlighten the need to establish quality parameters for collection, handling, processing and production of herbal medicine as well as employ such parameters in ensuring the safety of the global herbal market. It is necessary to introduce measures on the regulation of herbal medicines to ensure quality, safety, efficacy of herbal medicines by using modern suitable standards & GMP. The processes of good quality assurance and standardization of herbal medicines and products using various spectroscopic, chromatographic and electrophoretic methods were also discussed. In fact, the research field of quality control of herbal medicines is really an interdisciplinary research. It needs crossover of chemistry, pharmacology, medicine and even statistics to provide a platform for the quality control of traditional herbal medicines and further to discover the novel therapeutics composed of multiple chemical compounds. Keywords: Herbal drugs, Adulteration, Standardization, Chromatography, Electrophoresis, HP-LC and GC-MS.
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He, Chun Xia, Luo Ming Zhang, and Xiao Dong Wang. "Design of a Microwave Vacuum Drying Medicine Extract Model of Process Equipment." Key Engineering Materials 667 (October 2015): 562–67. http://dx.doi.org/10.4028/www.scientific.net/kem.667.562.

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In order to ensure the medicinal efficacy and improve the production efficiency, design and production of a kind of microwave vacuum drying medicine extract new technical equipment. Through analyzing the principle of material characteristics of traditional Chinese medicine extract, drying, microwave vacuum drying, Design of microwave vacuum drying chamber, cylinder body, a door body, a material system. Based on the overall scheme, the main structure parameters were calculated, and the production of a set of test equipment, the dehydration rate test. The new process equipment efficiency, reduces the cost, the volume is greatly reduced, keep the efficacy, and has the functions of sterilization, especially suitable for the production of proprietary Chinese medicines industry.
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Burylo, Y. P. "Novelties of the legislation on veterinary medicinal products." Uzhhorod National University Herald. Series: Law 66 (November 29, 2021): 142–46. http://dx.doi.org/10.24144/2307-3322.2021.66.24.

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The article is devoted to the analysis of the latest innovations in the legislation on veterinary medicine, namely the regulation of the production, distribution and use of veterinary medicines. The adoption of the new Law of Ukraine “On Veterinary Medicine” is caused by the need to approximate the relevant national legislation with the legislation of the European Union to fulfill Ukraine’s international obligations under the Association Agreement. This law reflects the latest trends in the development of legislation on veterinary medicinal products in the European Union. The article pays attention to the strengthening of state regulation of production and distribution of veterinary medicines, in particular the introduction of licensing of imports, wholesale and retail sales of these medicines in Ukraine, due to the need to combat counterfeiting and veterinary medicinal products of dubious quality. It is also noted that the changes in the procedure of state registration of veterinary medicines provided by this law will on the one hand reduce the administrative burden on business due to the transition to indefinite state registration of veterinary drugs, and on the other hand new requirements for the registration dossier will improve the safety, quality and efficacy of veterinary medicinal products. New requirements for the use of antibiotics are analyzed. Attention is drawn to the fact that along with the regulation of the use of antibiotics in animal husbandry, it is also necessary to regulate in more detail the issues of control of the circulation of active substances (active pharmaceutical ingredients). The article also deals with the mechanism of veterinary pharmacovigilance, which is new for Ukraine. At the same time, it is necessary to study the practical experience of implementing the European model of pharmaco to improve the relevant legislation in Ukraine.
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Koopmans, Marieke, Dirk Martens, and Rene Wijffels. "Towards Commercial Production of Sponge Medicines." Marine Drugs 7, no. 4 (December 2, 2009): 787–802. http://dx.doi.org/10.3390/md7040787.

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Poerwosusanta, Hery, Zairin Noor, Karyono Mintaroem, Edi Widjajanto, and Mulyohadi Ali. "Extraction the Dayak Onion (Eleutherine sp): Scientific Based Herbal Medicine (OHT) Production Protocol." Berkala Kedokteran 15, no. 2 (September 16, 2019): 133. http://dx.doi.org/10.20527/jbk.v15i2.7263.

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Abstract: Indonesia has the second largest tropical forest and the richest in flora biodiversity in the world. Based on the Basic Health Research 2010, 59.29% of Indonesian had consumed herbal medicine, noted that Indonesian had consumed herb since the VIII century. Dayak onion (Eleutherine sp) widely used as traditional medicine, as a bahimang /wound healing agent. Dayak onion is not reassured as a medical treatment and lacked scientific evidence. Until 2018, thousands of herbs consumed by Indonesian, only 85 ingredients clinically tested. Sixty-four herbs have been pre-clinically tested and designated as Scientific based Herbal Medicines/Obat Herbal Terstandar (OHT) and 21 herbs have been tested clinically and determined as Phytopharmaca by the Badan Pengawasan Obat dan Makanan Republik Indonesia (BPOM-RI). Based on the data, the Dayak onion appointed as a Scientific based Herbal medicine (OHT) based on pre-clinical and phase 0 clinical research. Potential and promising for the treatment of metabolic, degenerative, catastrophic, neoplasmic, genetic and infectious diseases, Dayak onions can be developed into phytopharmaca in the future. The study aim is to make guidelines for the standardized herbal medicines development according to the rules and regulations. Keywords: Dayak Onion, Eleutherine sp, Scientific based Herbal Medicines, Phytopharmaca, Pre Clinic and Clinical Trials phases
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Pattanayak, Shibabrata. "Anti-COVID-19 Biomedicines - A Layout Proposal for Production, Storage and Transportation." Open COVID Journal 1, no. 1 (November 24, 2021): 166–88. http://dx.doi.org/10.2174/2666958702101010166.

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Background: Modulation of non-specific immunity and other related activities of succulent parts of effective medicinal plants can prevent viral infections like COVID-19 through their dietary intake. Objective: The succulent parts of the medicinal plants with immunomodulation, anti-oxidation, anti-viral, anti-inflammatory, etc. power can be used orally in the capsular form to prevent as well as to reduce the severity of symptoms of COVID-19. Methods: A proposal is displayed with a detailed description of related steps like the selection of medicinal plant parts consulting related reports, collection of biomedicines, validation of efficacy, dosing, encapsulation, storage, and transportation, etc. Results: The succulent bio-medicines against COVID-19 can be developed and marketed following only some adoptive research. Conclusion: Succulent bio-medicines can be prepared and marketed for the prevention and cure of different infectious and non-infectious diseases.
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Dissertations / Theses on the topic "The production of medicines"

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Junior, Edison Claudino Bicudo. "O circuito superior marginal: produção de medicamentos e o território brasileiro." Universidade de São Paulo, 2006. http://www.teses.usp.br/teses/disponiveis/8/8136/tde-17072007-104024/.

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O presente trabalho pretende explorar o conceito de circuito superior marginal, proposto por Milton Santos em 1975. Esse conceito faz referência a um subsistema econômico presente nas cidades dos países do Terceiro Mundo. Nesse subsistema, encontramos ações que são, a um só tempo, ligadas às lógicas da modernização e dotadas de menor conteúdo em técnica, ciência e informação. Com isso, formam-se ações híbridas, que expressam tanto as racionalidades globais, instrumentais, como as racionalidades locais, comunicacionais. Para a realização desse estudo, cuidamos da produção de medicamentos no território brasileiro. Embora atentando para as novas condições de hegemonia dos laboratórios multinacionais, enfatizamos a situação dos pequenos laboratórios. Estes se dedicam a produções menos complexas e empregam técnicas e informações menos sofisticadas. Além disso, ficam submetidos ao controle político que os agentes hegemônicos passam a realizar, sobretudo em função dos aparelhos normativos que regulam as ações no território. Nessa medida, os pequenos produtores de medicamentos conformam, para a atividade farmacêutica, um circuito superior marginal. Nosso estudo quer entender as integrações desse circuito com o meio construído em várias situações urbanas brasileiras.
This work aims to explore the concept of marginal superior system, proposed by Milton Santos in 1975. This concept does reference to an economic subsystem that is presented in cities of Third World. In this subsystem we can find actions that are at the same time linked to the rationalities of the modernization and endowed with small contents in terms of technique, science, and information. Thus, hybrid actions emerge, expressing as global and instrumental rationalities as local and communicational rationalities. In order to develop this study, we are concerned about the production of medicines in the Brazilian territory. Though we consider the new conditions of hegemony from the multinational laboratories, we focused the situation of small laboratories. These latter ones develop less complex productions and employ less sophisticated techniques and information. Besides, they are submitted to the political control of the hegemonic actors, especially based on the normative tools that rule the actions in the territory. Thus, the small laboratories constitute, for the pharmaceutical activity, a marginal superior system. Our study aims to understand the linkages between this system and the built environment in several Brazilian urban situations.
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Van, Heerden Ilse. "Evaluation of a phytogenic product from two western herbal medicines to replace an antimicrobial growth promoter in poultry production." Thesis, University of Pretoria, 2010. http://hdl.handle.net/2263/28482.

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Antimicrobial growth promoters (AGPs) are substances that are added to feed in sub-therapeutic levels in intensive animal production to improve weight gain and conversion of feed (FCR) into body mass. AGPs have been used widely as growth promoters in broiler and pig production under high-density growth conditions. Despite the observed efficacy, the use of AGPs has been criticized due to its possible role in the development of antibiotic resistance in human pathogens. Directive 183/2003 of the European Parliament, issued in 2003, banned of the use of all antibiotic agents as growth promoters in the European Union from 2006. The new context caused an increase in the search for alternative growth promoters. The aim of this study was to produce a commercially viable prophylactic antibacterial phytogenic product from Ginkgo biloba and Hypericum perforatum with a low potential to develop resistance, as an alternative to AGPs in poultry production. The first objective of this study based on earlier results of the Phytomedicine Programme, was to evaluate the activity and potentize extracts from Ginkgo biloba and Hypericum perforatum for optimal activity against relevant bacterial pathogens. Extracts of ethyl acetate (EA), hexane, dichloromethane (DCM) and acetone (in order of activity) from a direct extraction procedure of powdered G. biloba leaves were active against Enterococcus faecalis, Staphylococcus aureus and Clostridium perfringens. The EA, hexane and DCM extracts were 2 to 3 times more active than the acetone extract (average total activity 1728 ml/g dry extract for the 3 pathogens). The DCM-, EA-, acetone- and hexane extracts (in order of activity) from the direct extraction procedure from H. perforatum were only active against C. perfringens with the first three extracts having a total activity of between 1026 and 1333 ml/g dry material and the hexane extract a total activity of 333 ml/g dry material. The spectrum of activity of G. biloba corresponds to that of Zn-bacitracin, which is commonly used an antibiotic growth promoter in the poultry industry. The second objective in this study was to combine extracts or fractions of extracts of G. biloba and H. perforatum to optimise activity against selected bacterial pathogens. A synergistic effect could be observed when combining a ratio of 1:5 of G. biloba: H. perforatum (hexane extracts) or 1:15 (acetone extracts) against E. faecalis while only an indifferent (neutral) effect was observed against C. perfringens. After elucidation of the quantitative and qualitative aspects involved in the antimicrobial activity, the major antibacterial compound from G. biloba was isolated and characterized as ginkgolic acid (C17:1). It was also determined whether activity against E. faecalis and C. perfringens in an extract or fraction of and extract of G. biloba can be attributed only to ginkgolic acid or whether synergism or other interactions also play a role in the antibacterial activity. It was shown that synergistic interactions are at play between constituents in the hexane and EA fraction, with the last mentioned fraction not containing any ginkgolic acid. These results support the use of the whole extract as opposed to isolated compounds as antimicrobial agents against pathogenic organisms. Two important pharmacodynamic parameters were investigated i.e. resistance development to a hexane extract and the isolated ginkgolic acid from G. biloba against E. faecalis and secondly the time-kill dynamics of this hexane extract over 24 h against E. faecalis. The bactericidal nature of the hexane extract from G. biloba as well the absence of decreased susceptibility to this extract (and the isolated ginkgolic acid) in the resistance studies against E. faecalis indicate that this extract has potential to be exploited as a alternative to AGPs in the poultry industry. The final objective was to determine the effect of extracts of G. biloba alone or in combination with H. perforatum extracts on the performance of broiler chickens over a 35 day period. The effect of these extracts on C. perfringens in the intestine of broilers was also investigated. No significant differences were found with relation to any of the production parameters studied (FCR, live weight or % survival) although a trend towards more favourable European Performance Efficiency Factor index values were observed for treatments containing G. biloba (5% improvement) or a combination of G. biloba and H. perforatum (2.1% improvement) compared to the untreated control. Similarly, Zn-Bacitracin resulted in a 5.5% improvement compared to the untreated control. There was a general trend (not statistically significant, P=0.05) towards a reduction in C. perfringens scores in the feed supplemented with G. biloba- in combination with H. perforatum extract which can probably be ascribed to the direct antimicrobial effect. The rate of colonization was however too low to cause infection probably due to lack of virulence of the C. perfringens challenge and the absence of predisposing factors due to the hygienic growth conditions used. It is necessary for an effective disease model to be developed in order for the efficacy of any new treatment method to be properly evaluated. Such a model will require a much higher incidence of disease and reproducibility than was achieved in this project. The safety of using extracts of G. biloba with ginkgolic acid as the prime antibacterial compound was considered. The active dose was at least 42 times lower than safe dosage recommended in the literature. The combination of extracts of G. biloba and H. perforatum holds promise as a potential growth promoter in poultry production. Better results may be achieved if potentized extracts are used and compared with Zn-Bacitracin and a negative control under industrial growth conditions where the birds are stressed and natural infections would take place. Copyright
Thesis (PhD)--University of Pretoria, 2009.
Paraclinical Sciences
unrestricted
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Beaney, Alison M. "The development and implementation of appropriate standards for the preparation and production of medicines." Thesis, University of Sunderland, 2010. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.514221.

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PUPILLO, Gaia. "Radioisotopes production via accelerator for nuclear medicine applications." Doctoral thesis, Università degli studi di Ferrara, 2014. http://hdl.handle.net/11392/2388938.

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SORTE, JUNIOR Waldemiro Francisco. "The Role of Governmental Policies in Nurturing the Pharmaceutical Industry in Brazil: The Mix of Centralized Procurement, Public Drug Production and Public-private Partnerships." 名古屋大学大学院国際開発研究科, 2012. http://hdl.handle.net/2237/16249.

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Böttcher, Malin, Jenny Fredriksson, Anna Hellquist, and Maria Jenmalm. "Effects of breast milk from allergic and non-allergic mothers on mitogen- and allergen-induced cytokine production." Linköpings universitet, Pediatrik, 2003. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-26400.

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Breast milk contains several components that provide specific immunity and affect the maturation of the infant's immune system. The aim of this study was to analyze the effects of breast milk, on mitogen- and allergen-induced cytokine production from cord blood mononuclear cells (CBMC), and if those effects differ between allergic and non-allergic mothers. The cells were incubated for 96 h with phytohemagglutinin (PHA), ovalbumin or cat dander in the presence of various dilutions of colostrum. Colostrum inhibited both mitogen- and cat-induced IFN-γ and mitogen-induced interleukin-4 (IL-4) production. The inhibition on IFN-γ production was to some extent caused by TGF-β, as the effect was modified when an anti-TGF-β antibody was added to the cultures. In contrast, colostrum enhanced allergen-induced production of the Th2-like cytokines IL-5 and IL-13, and this was accompanied with increased production of IL-10. No differences were found between allergic and non-allergic mothers. The inhibitory effect of breast milk on IFN-γ production, which was partly due to the high levels of TGF-β, together with the enhancing effect on IL-10 secretion, confirm that breast milk is anti-inflammatory. Although the production of IL-5 and IL-13 was enhanced by colostrum, this was accompanied with an increased production of IL-10. Together with the high levels of TGF-β in breast milk and inhibitory effect of colostrum on IL-4 production, this suggests a possible mechanism whereby breast-feeding may protect against the development of allergy. Despite differences in the composition of breast milk between allergic and non-allergic mothers, the effects of breast milk on cytokine production from CBMC were independent of the atopic status of the mothers.
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Abell, Kaitlynn M. "Predictive analytics and data management in beef cattle production medicine." Diss., Kansas State University, 2017. http://hdl.handle.net/2097/35418.

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Doctor of Philosophy
Department of Diagnostic Medicine/Pathobiology
Robert L. Larson
Bradley J. White
Utilization of data analytics allows for rapid and real-time decision making in the food animal production industry. The objective of my research was to implement and utilize different data analytic strategies in multiple sectors of the beef cattle industry in order to determine management, health, and performance strategies. A retrospective analysis using reproductive and genomic records demonstrated that a bull will sire a larger number of calves in a multiple sire-pasture compared to other bulls in the same pasture. A further study was performed to determine if behavior differences existed among bulls in a multiple-sire pasture, and the ability of accelerometers to predict breeding behaviors. Machine learning techniques used classifiers on accelerometer data to predict behavior events lying, standing, walking, and mounting. The classifiers were able to accurately predict lying and standing, but walking and mounting resulted in a lower predictable accuracy due to the extremely low prevalence of these behaviors. Finally, a new form of meta-analysis to the veterinary literature, a mixed treatment comparison, was able to accurately identify differences in metaphylactic antimicrobials on outcomes of bovine respiratory disease morbidity, mortality, and retreatment morbidity. The meta-analysis was not successful in determining the effects of metaphylactic antimicrobials on performance outcomes.
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MARTINI, Petra. "High-Yield Cyclotron Production of Metallic Radioisotopes for Nuclear Medicine." Doctoral thesis, Università degli studi di Ferrara, 2018. http://hdl.handle.net/11392/2487885.

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The main purpose of LARAMED project (LAboratoty of Radioisotopes for MEDicine), founded at LNL-INFN, is the R&D on cyclotron production of conventional, such as Tc-99m (TECHN-OSP projects), and emerging, such as Cu-67 (COME project), metallic medical radioisotopes. The aim of my PhD has been the development, optimization and automation of post-irradiation target processing systems, enabling to recover in high yield highly pure radioisotopes (RI), one of the most critical steps in the RI cyclotron production. The possibility of a reactor-produced molybdenum-99 shortage, used as parent nuclide of in 99Mo/99m Tc generators, is still a potential scenario. The direct cyclotron-production of Tc-99m through the (p,2n) reaction on a Mo-100 target seemed to be a reliable solution. In the framework of TECHN-OSP project, a technology for enabling the in-hospital cyclotron self-production of Tc-99m, in order to afford the availability of the most used radiometal in diagnostic applications in case of shortages, has been developed. The Tc-99m cyclotron-production optimization included the design of a solid target, the development of an automatic module for target processing and enriched target material recovery study. In this thesis, the description of Tc-99m production experiments, performed in collaboration with the Sant’Orsola Hospital in Bologna, and the development of the automatic module for target processing, are well detailed. During my PhD I had the opportunity to collaborate with the Canadian research group at TRIUMF (Vancouver, CA), also working on Tc-99m cyclotron-production, by contributing at the optimization and automation of molybdenum target dissolution and purification procedure of cyclotron-produced Tc-99m. In this thesis a comparison between the two developed, Italian and Canadian, target processing setup is also reported. Alongside that, I have collaborated to COME project whose purpose is the evaluation of the cyclotron production efficiency of Cu-67, a particularly interesting RI for its application in “theranostics”. The large scale cyclotron-production of this RI is still a poorly studied key point. In order to define the Cu-67 best cyclotron-production route, we focused our attention on unknown cross-section measurement of nuclear reactions on a Zn-70 target (35-70MeV energy range). Essential for this project was the development and optimization of a high yield separation and purification procedure of Cu-67 from the Zn-70 bulk and the co-produced Ga-67 contaminant that, having the same γ-lines of Cu-67 (both decay to Zn-67 with similar half-lives), poses a serious issue for the determination of the activity of Cu-67. The description of the experiments, performed in collaboration with ARRONAX, is reported in this thesis. Finally, the clinical needs of larger amount of the PET radiometal generator-produced Ga-68 prompted TRIUMF Life Sciences division to investigate Ga-68 cyclotron-production from liquid target since it is based on the existing medical-cyclotron network and technology. This technique will improve the availability of Ga-68 in hospitals housing an appropriate cyclotron by making them independent self-producers. Since the major problem affecting liquid targets is the contamination with radioactive/stable metals (e.g. iron) coming from the dissolution of some material from vacuum isolation or target body components during the irradiation, a separation and purification procedure together with a semi-automatic system, particularly focused on the purification of Ga-68 from Zn and Fe, have been developed. The main purpose is to obtain a final product suitable for medical use and to enable radiolabeling and in-vivo imaging studies with cyclotron produced 68Ga-DOTATOC.
Il progetto LARAMED (LAboratoty of Radioisotopes for MEDicine), fondato presso i LNL-INFN, ha come scopo l’R&D per la produzione da ciclotrone di radioisotopi metallici convenzionali, come il Tc-99m (progetto TECHN-OSP, ed emergenti, come il Cu-67 (progetto COME), per uso medicale. L'obiettivo del mio dottorato di ricerca è stato lo sviluppo, ottimizzazione e automazione di sistemi di processamento dei target irraggiati al fine di estrarre, in alta resa e purezza, il radioisotopo (RI) di interesse, uno dei passaggi più critici nella produzione da ciclotrone dei RI per la medicina. La possibilità di un’ulteriore crisi di produzione da reattori nucleari di Mo-99, nuclide genitore nei generatori Mo-99/Tc-99m, è ancora uno scenario possibile. La produzione diretta di Tc-99m da ciclotrone per mezzo della reazione nucleare Mo-100(p,2n) sembra essere una soluzione alternativa affidabile. Nell’ambito del progetto TECHN-OSP è stata sviluppata una tecnologia in grado di rendere le radiofarmacie delle Medicine Nucleari, che ospitano un ciclotrone appropriato, indipendenti nella produzione di Tc-99m al fine di sopperire ad ogni eventuale carenza nell’approvvigionamento dei generatori. L’ottimizzazione della produzione ha previsto la progettazione di un target, lo sviluppo di un modulo automatico per il processamento del target e lo studio del recupero del materiale arricchito costituente il target stesso. In questa tesi sono descritti i test di produzione di Tc-99m, eseguiti in collaborazione con l'ospedale Sant'Orsola di Bologna, ed in particolare lo sviluppo di un modulo automatico di processamento del target. Nel corso del dottorato, ho avuto l'opportunità di collaborare con il gruppo di ricerca canadese al TRIUMF (Vancouver, CA), anch’esso coinvolto nell’ottimizzazione della produzione di Tc-99m da ciclotrone, contribuendo all'ottimizzazione e automazione delle procedure di dissoluzione e purificazione di Tc-99m da target di Mo-100. In questa tesi viene anche riportato un confronto tra i due sistemi di processamento target da me sviluppati, in Italia e in Canada. Parallelamente ho collaborato al progetto COME il cui obiettivo risiede nella valutazione dell'efficienza di produzione di Cu-67 da ciclotrone, RI particolarmente interessante per le sue applicazioni in “teranostica”. La produzione da ciclotrone su larga scala di questo RI è ancora un punto chiave scarsamente studiato. Al fine di definire la migliore via di produzione di Cu-67, abbiamo focalizzato l’attenzione su misure di sezioni d’urto inedite (target Zn-70, protoni incidenti di energie 35-70MeV). Essenziale per questo progetto è stato lo sviluppo di un processo altamente efficiente di separazione di Cu-67 dal target e dal Ga-67, coprodotto che, avendo le stesse linee γ del Cu-67, crea problemi nella determinazione dell'attività di Cu-67. La descrizione degli esperimenti, eseguita in collaborazione con ARRONAX, è riportata in questa tesi. Infine, le esigenze cliniche di una maggiore quantità di Ga-68, RI PET attualmente prodotto da generatore Ge-68/Ga-68, hanno spinto il gruppo di ricerca del TRIUMF a studiare la produzione di Ga-68 da ciclotrone a partire da un target liquido di Zn-68, al fine di migliorare la disponibilità di Ga-68 negli ospedali che ospitano un ciclotrone appropriato rendendoli produttori indipendenti. Poiché il problema principale che colpisce la produzione da target liquido è la contaminazione da metalli (es. Fe) provenienti dalla degradazione di alcuni componenti del corpo del target, è stata sviluppata una procedura di separazione e purificazione del Ga-68 da Zn e Fe. Lo scopo principale è quello di ottenere un prodotto finale adatto all’uso medico e di consentire la radio-marcatura di (Ga-68)-DOTATOC e studi di imaging in vivo con Ga-68 prodotto da ciclotrone.
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Robson, Jo. "Neologism production in jargon aphasia." Thesis, City, University of London, 1998. http://openaccess.city.ac.uk/17418/.

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This study investigates a jargon speaker, LT, whose connected speech is composed almost entirely of neologisms. Despite the general intelligibility of his speech, LT is able to produce discrete responses in picture naming tasks. Neologisms were investigated for their phonemic content. Non word responses maintained the normal English distribution of phonemes. Importantly, they also showed greater than chance levels of target relatedness. Analysis of LT's responses to a set of stimuli controlled for their consonant content allowed more detailed investigation of the nature of target and error phonology. A strong influence of phoneme frequency was identified. Higher frequency consonants showed a pattern of frequent but rather indiscriminate use. They often appeared in target related contexts but were also frequently misused in contexts where they were not required by the target phonology. Lower frequency consonants were realised less often. However, their use was restricted to target related contexts and they seldom appeared as error phonology. Further investigation showed that LT's ability to realise target phonology was influenced by the nature of the output task. A semantically primed reading condition resulted in a significant increase in the number of correct responses. Neologistic output showed a significant increase in the ability to realise target phonemes. Patterns of individual consonant use also showed significant changes. High frequency consonants showed a more refined distribution, appearing less frequently as error phonology. Low frequency consonants increased their rate of use but continued to be restricted to target related contexts. The findings of the investigations are discussed. The results are best explained by theories of neologism production which maintain a direct relationship between target and neologistic phonology and which propose a single mechanism underlying the production of both target related and abstruse neologistic output. Interactive activation accounts of lexical processing appear to be well placed to explain LT's output and a preliminary account is offered. Recommendations for the future investigation of neologistic output are made.
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Field, Helen. "On production of recombinant immunoglobulin variable domains." Thesis, University of Oxford, 1988. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.330288.

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Books on the topic "The production of medicines"

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Risco, Carlos A., and Pedro Melendez Retamal, eds. Dairy Production Medicine. Oxford, UK: Blackwell Publishing Ltd., 2011. http://dx.doi.org/10.1002/9780470960554.

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Ridenour, Ken Wesley. Beef production medicine. 7th ed. Canyon, Tex: Palo Duro Consultation Research and Feedlot, 2002.

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Risco, Carlos A., and Pedro Melendez. Dairy production medicine. Ames, Iowa: Wiley-Blackwell, 2011.

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1957-, Ridenour Ken Wesley, Bechtol David T, Merial (Firm), Palo Duro Consultation Research and Feedlot., and Global Animal Products Inc, eds. Beef production medicine. 8th ed. Canyon, Tex: Palo Duro Consultation Research and Feedlot, 2004.

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Risco, Carlos A., and Pedro Melendez. Dairy production medicine. Ames, Iowa: Wiley-Blackwell, 2011.

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Publications, Animal Health. Dairy: Production, medicine & management. S.l.]: Animal Health Publications, 1999.

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Hirt, Hans-Martin. Natural medicine in the tropics: Tropical plants as a source of health care - production of medicines and cosmetics. Winnenden: Action for Nature and Medicine (ANAMED), 1995.

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Thailand) FAO/AAHRI Expert Workshop on Improving Biosecurity through Prudent and Responsible Use of Veterinary Medicines in Aquatic Food Production (2009 Bangkok. Improving biosecurity through prudent and responsible use of veterinary medicines in aquatic food production. Rome: Food and Agriculture Organization of the United Nations, 2012.

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Hirt, Hans Martin. Natural medicine in the tropics 1: Foundation text : tropical plants as a source of health care : production of medicines and cosmetics. 3rd ed. Winnenden, Germany: Anamed, 2008.

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Hirt, Hans Martin. Natural medicine in the tropics 1: Foundation text : tropical plants as a source of health care : production of medicines and cosmetics. 3rd ed. Winnenden, Germany: Anamed, 2008.

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Book chapters on the topic "The production of medicines"

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Sawarkar, Sudhir, and Asawari Bapat. "Global Regulatory Frameworks and Quality Standards for Stem Cells Therapy and Regenerative Medicines." In Stem Cell Production, 69–111. Singapore: Springer Singapore, 2022. http://dx.doi.org/10.1007/978-981-16-7589-8_4.

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Hefferon, Kathleen. "Production of Medicines from Engineered Proteins in Plants." In Plant Biotechnology, 217–29. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-68345-0_15.

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Chaudhuri, Sudip. "Can Foreign Firms Promote Local Production of Pharmaceuticals in Africa?" In Making Medicines in Africa, 103–21. London: Palgrave Macmillan UK, 2016. http://dx.doi.org/10.1007/978-1-137-54647-0_7.

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Gebre-Mariam, Tsige, Kedir Tahir, and Solomon Gebre-Amanuel. "Bringing Industrial and Health Policies Closer: Reviving Pharmaceutical Production in Ethiopia." In Making Medicines in Africa, 65–84. London: Palgrave Macmillan UK, 2016. http://dx.doi.org/10.1007/978-1-137-54647-0_5.

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Marshall, P. David, and Joanne Morreale. "From Production to Consumption: The Rise of Patent Medicines." In Advertising and Promotional Culture, 11–29. London: Macmillan Education UK, 2017. http://dx.doi.org/10.1057/978-1-137-02625-5_2.

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Delgado, Julio, Claire Roddie, and Michael Schmitt. "Point-of-Care Production of CAR-T Cells." In The EBMT/EHA CAR-T Cell Handbook, 45–49. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-94353-0_8.

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AbstractCAR-T cells for clinical application are classified as advanced therapy medicinal products (ATMPs), and their manufacture is subject to laws and regulations governed by the European Medicines Agency (EMA) and by federal and regional authorities. CAR-T cells must be manufactured to achieve good manufacturing practice (GMP) compliance and are defined as potent products manufactured safely according to standardized methods under closely controlled, reproducible, and auditable conditions. BioPharma supplies the vast majority of CAR-T products for patients, but some academic centres have developed point-of-care cGMP CAR-T manufacturing capability, striving to uphold the same stringency of product quality while improving patient access to CAR-T cells and streamlining the costs of therapy. Point-of-care CAR-T manufacturing can only be performed in facilities with the appropriate regulatory approvals in place.
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Nahler, Gerhard. "production." In Dictionary of Pharmaceutical Medicine, 147. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_1130.

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Gray, Andrew L., and Yousuf A. Vawda. "TRIPS, Access to Medicines and Local Production in South Africa." In The New Political Economy of Pharmaceuticals, 185–203. London: Palgrave Macmillan UK, 2013. http://dx.doi.org/10.1057/9781137315854_10.

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Deuflhard, Peter, Olaf Dössel, Alfred K. Louis, and Stefan Zachow. "More Mathematics into Medicine!" In Production Factor Mathematics, 357–78. Berlin, Heidelberg: Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-642-11248-5_19.

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Son, Sung Ho, and Kee Yoeup Paek. "Large-Scale Production of Medicinal Plant Species: The Application of Bioreactors for Production of Ginseng Roots." In Development of Plant-Based Medicines: Conservation, Efficacy and Safety, 139–50. Dordrecht: Springer Netherlands, 2001. http://dx.doi.org/10.1007/978-94-015-9779-1_8.

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Conference papers on the topic "The production of medicines"

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Postnikova, M. E., and M. N. Shurupova. "Medicinal plants of the Tomsk region: questions of economic botany." In Problems of studying the vegetation cover of Siberia. TSU Press, 2020. http://dx.doi.org/10.17223/978-5-94621-927-3-2020-32.

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Some scientific problems in the economic botany area are represented in the article. The list of medicinal plants that were grown on the territory of the Tomsk region was complied and analyzed. According to the literature, the degree of knowledge of the resources of medicinal plants in the Tomsk region was determined. We investigated Tomsk drugstores’ assortment of drugs plant species of the Tomsk region have been identified, which can be used in the production of medicines to meet the demand in this territory.
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"Utilization of Bali Traditional Medicines Formula as an Additional Feed for Bali Cattle." In Technology Innovations and Collaborations in Livestock Production for Sustainable Food Systems. IAARD Press, 2021. http://dx.doi.org/10.14334/proc.intsem.lpvt-2021-p.26.

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Умархажиева, Мелек Зебитовна. "SUBSTANDARD MEDICINES AND LEGAL CONSEQUENCES OF THEIR IMPLEMENTATION." In Высокие технологии и инновации в науке: сборник избранных статей Международной научной конференции (Санкт-Петербург, Ноябрь 2020). Crossref, 2020. http://dx.doi.org/10.37539/vt188.2020.84.34.009.

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В статье исследована проблема оборота недоброкачественных лекарственных средств в мире и на территории России. Рассмотрена статистика выявления и изъятия недоброкачественных лекарственных средств на территории России. Выявлены основные причины производства и распространения таких средств. Отмечена роль Федеральной службы по надзору в сфере здравоохранения России (Росздравнадзора) в борьбе с указанным фальсификатом, а также правовые последствия за их оборот. This article examines the problem of turnover of substandard medicines in the world and in Russia. Statistics of detection and withdrawal of substandard medicines in Russia are considered. The main reasons for the production and distribution of such funds are identified. The role of the Federal service for supervision of healthcare in Russia (Roszdravnadzor) in the fight against these funds, as well as the legal consequences for their turnover, is noted.
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Kornyushko, V. F., O. M. Nikolaeva, S. YU Zolotov, O. V. Kryukova, and L. V. Sadekov. "Intelligent information technology in experimental research of development of finished dosage forms (GLF) in the production medicines." In SCIENCE OF RUSSIA: GOALS AND OBJECTIVES. L-Journal, 2021. http://dx.doi.org/10.18411/sr-10-02-2021-22.

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Huzayyin, O. A., M. S. El Morsi, M. A. Serag-Eldin, and M. F. El-Bedaiwy. "Prototype for Solar Powered Chip-Ice Production Facility." In ASME 2017 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/imece2017-72510.

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Fishermen in highly isolated communities like Shallatin and Halayeb (Southern Egypt) suffer from the fouling of their catch before reaching the markets, due to the prevailing high ambient temperatures. Thus, they resort to block or crushed ice to cool their catch. Since fresh water is unavailable naturally, energy is needed to produce the fresh water from sea water, as well as to operate the chiller for ice production. Hence, employing solar energy as the sole source of energy for manufacturing ice, and producing the ice straight from saline water provides independence from both the electric grid and fresh water resources. A prototype solar powered facility for chip ice production from saline water has been designed, manufactured and erected in Shallatin for this purpose. The prototype, basically an ice production machine provides facilities for fish chilling and refrigeration compartments for vaccines, medicines and food products. The produced ice can be easily transported in to fishing boats in 10 kg plastic boxes that are easy to carry and handle. The prototype design employs many standard parts to cut costs and development time. Adequate ventilation with natural heat leakage to the cool surfaces of equipment (e.g. external surfaces of tanks and their piping) produces the desired room temperature without need for a fan coil unit, as discovered in actual implementation. The design should be applicable to all environments similar to Halayeb and Shellatin, which includes many places on the Red sea in the Gulf area and Africa. It is thus expected to be attractive for commercial exploitation in those places, and offers opportunities for local manufacturing and exportation of industrial products.
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Сидуллина, Светлана Анатольевна. "THE ROLE OF THE PRODUCTION PRACTICE FOR QUALITY CONTROL OF MEDICINES IN THE PREPARATION OF A PHARMACIST WITH A HIGHER EDUCATION." In Проблемы управления качеством образования: сборник избранных статей Международной научно-методической конференции (Санкт-Петербург, Март 2022). Crossref, 2022. http://dx.doi.org/10.37539/ko196.2022.65.52.002.

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Введение нового образовательного стандарта в систему фармацевтического образования требует новых подходов к организации учебного процесса. Качество образования выпускников Института фармации КазГМУ напрямую зависит от организации производственной практики на выпускном курсе. В процессе подготовки специалиста-провизора важна роль производственной практики по контролю качества лекарственных средств. The introduction of a new educational standard into the pharmaceutical education system requires new approaches to the organization of the educational process. The quality of education of graduates of the Institute of Pharmacy of Kazan State Medical University directly depends on the organization of industrial practice in the final year. In the process of training a pharmacist, the role of manufacturing practice for quality control of medicines is important.
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Kadic, Enes, and Theodore J. Heindel. "Hydrodynamic Considerations in Bioreactor Selection and Design." In ASME 2010 3rd Joint US-European Fluids Engineering Summer Meeting collocated with 8th International Conference on Nanochannels, Microchannels, and Minichannels. ASMEDC, 2010. http://dx.doi.org/10.1115/fedsm-icnmm2010-30367.

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The biological production of renewable fuels and chemicals, medicines, and proteins is not possible without a properly functioning bioreactor. Bioreactors are expected to meet several basic requirements and create conditions favorable to the biological material such that the desired production is maximized. The basic requirements, which are strongly influenced by fluid mechanic principles, may include minimum damage to the biological material, maximum reactor volume utilization, optimized gas-liquid mass transfer, and/or enhanced mass transfer from the liquid to the biological species. Each of these goals may be achieved within any of the major bioreactor designs, which generally fall under the categories of stirred tank, bubble column, or airlift bioreactor. Yet, each of the bioreactor designs has strengths and weaknesses. This paper provides an overview of bioreactor hydrodynamic developments and the fluid mechanic issues that should to be considered when selecting a bioreactor for experimental and production purposes.
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Kodash, Artemii, Anna Basevich, Tatiana Bitkina, Elena Smirnova, and Irina Kaukhova. "Audit of the Production of Sterile Medicines for Compliance with the Requirements of the Draft EU GMP Annex 1 with Risk Analysis." In Proceedings of the 1st International Symposium Innovations in Life Sciences (ISILS 2019). Paris, France: Atlantis Press, 2019. http://dx.doi.org/10.2991/isils-19.2019.36.

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Zharkova, E. K., A. A. Vankova, and N. V. Drenova. "MICROBIAL PESTICIDES IN MEDICINAL CROP PRODUCTION." In 90 лет - от растения до лекарственного препарата: достижения и перспективы. Москва: Федеральное государственное бюджетное научное учреждение "Всероссийский научно-исследовательский институт лекарственных и ароматических растений", 2021. http://dx.doi.org/10.52101/9785870191003_2021_112.

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O.S., Popova. "Plant components of wormwood and thyme repens and their effect on nuclear receptors." In SPbVetScience. FSBEI HE St. Petersburg SUVM, 2023. http://dx.doi.org/10.52419/3006-2022-7-70-72.

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Plants have great potential to produce a wide range of secondary metabolites that have beneficial qualities that can be used as medicines to treat diseases in humans and animals. Taking into account the direction of development and the strategy of the Government of the Russian Federation, the primary task facing the scientists of the country is to ensure high productivity of animals, while maintaining organic production ("green mark"). For a qualitative study of plants that can be highly effectively used, it is necessary to analyze the already accumulated knowledge and conduct our own exploratory studies in vivo.
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Reports on the topic "The production of medicines"

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Leuschen, Bruce. Dairy Section of Veterinary Diagnostic and Production Animal Medicine (VDPAM). Ames (Iowa): Iowa State University, January 2011. http://dx.doi.org/10.31274/ans_air-180814-140.

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Leuschen, Bruce. Dairy Section of Veterinary Diagnostic and Production Animal Medicine (VDPAM). Ames (Iowa): Iowa State University, January 2010. http://dx.doi.org/10.31274/ans_air-180814-637.

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Leuschen, Bruce. Dairy Section of Veterinary Diagnostic and Production Animal Medicine (VDPAM). Ames (Iowa): Iowa State University, January 2009. http://dx.doi.org/10.31274/ans_air-180814-654.

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Leuschen, Bruce. Dairy Section of Veterinary Diagnostic and Production Animal Medicine (VDPAM). Ames (Iowa): Iowa State University, January 2012. http://dx.doi.org/10.31274/ans_air-180814-907.

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Collington, Rosie, and William Lazonick. Pricing for Medicine Innovation: A Regulatory Approach to Support Drug Development and Patient Access. Institute for New Economic Thinking Working Paper Series, January 2022. http://dx.doi.org/10.36687/inetwp176.

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The United States represents the world’s largest market for pharmaceutical drugs. It is also the only advanced economy in the world that does not regulate drug prices. There is no upper threshold for the prices of medicines in the United States. List prices are instead set by manufacturers in negotiation with supply-chain intermediaries, though some federal programs have degrees of discretion in price determinations. In practice, this deregulated system means that drug prices in the United States are generally far higher than in other advanced economies, adversely affecting patient accessibility and system affordability. In this paper, we draw on the “theory of innovative enterprise” to develop a framework that provides both a critique of the existing pricing system in the United States and a foundation for developing a new model of pricing regulation to support safety and effectiveness through drug development as well as accessibility and affordability in the distribution of approved medicines to patients. We introduce a regulatory approach we term “Pricing for Medicine Innovation” (PMI), which departs dramatically from the market-equilibrium assumptions of conventional (neoclassical) economics. The PMI approach recognizes the centrality of collective investments by government agencies and business firms in the productive capabilities that underpin the drug development process. PMI specifies the conditions under which, at the firm level, drug pricing can support both sustained investment in these capabilities and improved patient access. PMI can advance both of these objectives simultaneously by regulating not just the level of corporate profit but also its allocation to reinvestment in the drug development process. PMI suggests that although price caps are likely to improve drug affordability, there remain two potential issues with this pricing approach. Firstly, in an innovation system where a company’s sales revenue is the source of its finance for further drug development, price caps may deprive a firm of the means to invest in innovation. Secondly, even with adequate profits available for investment in innovation, a firm that is run to maximize shareholder value will tend to use those profits to fund distributions to shareholders rather than for investment in drug innovation. We argue that, if implemented properly, PMI could both improve the affordability of medicines and enhance the innovative performance of pharmaceutical companies.
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Zuckerman, Kenneth S. Reparative Medicine: Production of Erythrocytes & Platelets from Human Embryonic Stem Cells. Fort Belvoir, VA: Defense Technical Information Center, October 2012. http://dx.doi.org/10.21236/ada566171.

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Tanna, Sangeeta, and Rachel Armitage. Poor-quality medicines are everyone’s problem. Edited by Sarah Bailey. Monash University, July 2022. http://dx.doi.org/10.54377/2248-8316.

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Jaspars, Marcel. Diving into the abyss for new medicines. Monash University, February 2022. http://dx.doi.org/10.54377/4ebb-235d.

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Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern. Characterizing the Drug Development Pipeline for Precision Medicines. Cambridge, MA: National Bureau of Economic Research, November 2017. http://dx.doi.org/10.3386/w24026.

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Lubowa, Nasser, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Pharmaceutical Industry in Uganda: A Review of the Common GMP Non-conformances during Regulatory Inspections. Purdue University, December 2021. http://dx.doi.org/10.5703/1288284317442.

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Abstract:
The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (GEE) model was applied to estimate the association between odds of a company failing to comply with the GMP requirements and non-conformances under each GMP inspection parameter. Analysis using dummy estimation to linear regression included determination of the relationship that existed between the selected variables (GMP inspection parameters) and the production capacity of the local pharmaceutical industry. Oral liquids, external liquid preparations, powders, creams, and ointments were the main categories of products manufactured locally. The results indicated that 86% of the non-conformances were major, 11% were minor, and 3% critical. The majority of the non-conformances were related to production (30.1%), documentation (24.5%), and quality control (17.6%). Regression results indicated that for every non-conformance under premises, equipment, and utilities, there was a 7-fold likelihood of the manufacturer failing to comply with the GMP standards (aOR=6.81, P=0.001). The results showed that major non-conformances were significantly higher in industries of small scale (B=6.77, P=0.02) and medium scale (B=8.40, P=0.04), as compared to those of large scale. This study highlights the failures in quality assurance systems and stagnated GMP improvements in these industries that need to be addressed by the manufacturers with support from the regulator. The addition of risk assessment to critical production and quality control operations and establishment of appropriate corrective and preventive actions as part of quality management systems are required to ensure that quality pharmaceuticals are manufactured locally.
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