Relevant bibliographies by topics / Pharmaceutical processes

Academic literature on the topic 'Pharmaceutical processes'

Author: Grafiati
Published: 10 December 2022
Last updated: 29 January 2023

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Journal articles on the topic "Pharmaceutical processes"

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Lucena, Alex Leandro Andrade de, Daniella Carla Napoleão, Hélder Vinícius Carneiro da Silva, Rayany Magali da Rocha Santana, Beatriz Galdino Ribeiro, and Marta Maria Menezes Bezerra Duarte. "Degradation of the pharmaceuticals lamivudine and zidovudine using advanced oxidation processes." Ciência e Natura 42 (September 3, 2020): e9. http://dx.doi.org/10.5902/2179460x40071.

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The existence of pharmaceuticals in nature is a growing environmental problem, turning necessary the use of efficient treatments for the degradation of these substances, as the advanced oxidation processes (AOPs). In this work the AOPs UV/H2O2 and photo-Fenton were applied to degrade the pharmaceuticals lamivudine and zidovudine in an aqueous solution using a bench reactor, composed of three UV-C lamps. It was verified that the UV/H2O2 process presented a degradation of 97.33 ± 0.14% for lamivudine and 93.90 ± 0.33% for zidovudine, after 180 min of treatment and for an initial concentratin of each pharmaceutical of 5 mg.L-1 and [H2O2] of 600 mg.L-1. A methodology by artificial neural networks (ANNs) was used to model the photocatalytic process, with the MLP 7-23-2 ANN representing it well, and determining the relative importance (%) of each of the input variables for the pharmaceutical’s degradation process. Kinetic studies for the pharmaceutical degradation and the conversion of organic matter showed good adjustments to the pseudo first-order models with R2 raging from 0.9705 to 0.9980. Toxicity assays for the before treatment solution indicated that the seeds Lactuca sativa and Portulaca grandiflora showed growth inhibition whereas the post-treatment solution inhibited only the growth of Lactuca sativa.
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Lucena, Alex Leandro Andrade de, Daniella Carla Napoleão, Hélder Vinícius Carneiro da Silva, Rayany Magali Da Rocha Santana, Beatriz Galdino Ribeiro, and Marta Maria Menezes Bezerra Duarte. "Degradation of the pharmaceuticals lamivudine and zidovudine using advanced oxidation processes." Ciência e Natura 42 (September 3, 2020): e30. http://dx.doi.org/10.5902/2179460x40968.

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The existence of pharmaceuticals in nature is a growing environmental problem, turning necessary the use of efficient treatments for the degradation of these substances, as the advanced oxidation processes (AOPs). In this work the AOPs UV/H2O2 and photo-Fenton were applied to degrade the pharmaceuticals lamivudine and zidovudine in an aqueous solution using a bench reactor, composed of three UV-C lamps. It was verified that the UV/H2O2 process presented a degradation of 97.33 ± 0.14% for lamivudine and 93.90 ± 0.33% for zidovudine, after 180 min of treatment and for an initial concentratin of each pharmaceutical of 5 mg.L-1 and [H2O2] of 600 mg.L-1. A methodology by artificial neural networks (ANNs) was used to model the photocatalytic process, with the MLP 7-23-2 ANN representing it well, and determining the relative importance (%) of each of the input variables for the pharmaceutical’s degradation process. Kinetic studies for the pharmaceutical degradation and the conversion of organic matter showed good adjustments to the pseudo first-order models with R2 raging from 0.9705 to 0.9980. Toxicity assays for the before treatment solution indicated that the seeds Lactuca sativa and Portulaca grandiflora showed growth inhibition whereas the post-treatment solution inhibited only the growth of Lactuca sativa.
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Smyth, C. "Sounding Out Pharmaceutical Processes." Journal of the Association for Laboratory Automation 8, no. 4 (August 1, 2003): 46–49. http://dx.doi.org/10.1016/s1535-5535(04)00279-5.

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Smyth, Cormac, Evgeny Kudriashov, Breda O'Driscoll, and Vitaly Buckin. "Sounding Out Pharmaceutical Processes." JALA: Journal of the Association for Laboratory Automation 8, no. 4 (August 2003): 46–49. http://dx.doi.org/10.1016/s1535-5535-04-00279-5.

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Mansouri, Fatma, Khawla Chouchene, Nicolas Roche, and Mohamed Ksibi. "Removal of Pharmaceuticals from Water by Adsorption and Advanced Oxidation Processes: State of the Art and Trends." Applied Sciences 11, no. 14 (July 20, 2021): 6659. http://dx.doi.org/10.3390/app11146659.

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Pharmaceutical products have become a necessary part of life. Several studies have demonstrated that indirect exposure of humans to pharmaceuticals through the water could cause negative effects. Raw sewage and wastewater effluents are the major sources of pharmaceuticals found in surface waters and drinking water. Therefore, it is important to consider and characterize the efficiency of pharmaceutical removal during wastewater and drinking-water treatment processes. Various treatment options have been investigated for the removal/reduction of drugs (e.g., antibiotics, NSAIDs, analgesics) using conventional or biological treatments, such as activated sludge processes or bio-filtration, respectively. The efficiency of these processes ranges from 20–90%. Comparatively, advanced wastewater treatment processes, such as reverse osmosis, ozonation and advanced oxidation technologies, can achieve higher removal rates for drugs. Pharmaceuticals and their metabolites undergo natural attenuation by adsorption and solar oxidation. Therefore, pharmaceuticals in water sources even at trace concentrations would have undergone removal through biological processes and, if applicable, combined adsorption and photocatalytic degradation wastewater treatment processes. This review provides an overview of the conventional and advanced technologies for the removal of pharmaceutical compounds from water sources. It also sheds light on the key points behind adsorption and photocatalysis.
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Kang, Bo Ram, Min Sung Kim, and Tae Kwon Lee. "Unveiling of Concealed Processes for the Degradation of Pharmaceutical Compounds by Neopestalotiopsis sp." Microorganisms 7, no. 8 (August 16, 2019): 264. http://dx.doi.org/10.3390/microorganisms7080264.

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The presence of pharmaceutical products has raised emerging biorisks in aquatic environments. Fungi have been considered in sustainable approaches for the degradation of pharmaceutical compounds from aquatic environments. Soft rot fungi of the Ascomycota phylum are the most widely distributed among fungi, but their ability to biodegrade pharmaceuticals has not been studied as much as that of white rot fungi of the Basidiomycota phylum. Herein, we evaluated the capacity of the soft rot fungus Neopestalotiopsis sp. B2B to degrade pharmaceuticals under treatment of woody and nonwoody lignocellulosic biomasses. Nonwoody rice straw induced laccase activity fivefold compared with that in YSM medium containing polysaccharide. But B2B preferentially degraded polysaccharide over lignin regions in woody sources, leading to high concentrations of sugar. Hence, intermediate products from saccharification may inhibit laccase activity and thereby halt the biodegradation of pharmaceutical compounds. These results provide fundamental insights into the unique characteristics of pharmaceutical degradation by soft rot fungus Neopestalotiopsis sp. in the presence of preferred substrates during delignification.
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Zhou, Lilong, Chen Ma, Jonathan Horlyck, Runjing Liu, and Jimmy Yun. "Development of Pharmaceutical VOCs Elimination by Catalytic Processes in China." Catalysts 10, no. 6 (June 13, 2020): 668. http://dx.doi.org/10.3390/catal10060668.

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As a byproduct of emerging as one of the world’s key producers of pharmaceuticals, China is now challenged by the emission of harmful pharmaceutical VOCs. In this review, the catalogue and volume of VOCs emitted by the pharmaceutical industry in China was introduced. The commonly used VOC removal processes and technologies was recommended by some typical examples. The progress of catalytic combustion, photocatalytic oxidation, non-thermal plasma, and electron beam treatment were presented, especially the development of catalysts. The advantages and shortages of these technologies in recent years were discussed and analyzed. Lastly, the development of VOCs elimination technologies and the most promising technology were discussed.
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Fujiwara, Mitsuko, David L. Ma, Timokleia Togkalidou, Danesh K. Tafti, and Richard D. Braatz. "IDENTIFICATION OF PHARMACEUTICAL CRYSTALLIZATION PROCESSES." IFAC Proceedings Volumes 35, no. 1 (2002): 253–58. http://dx.doi.org/10.3182/20020721-6-es-1901.01351.

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Kellaway, Ian. "Transport Processes in Pharmaceutical Systems." International Journal of Pharmaceutics 228, no. 1-2 (October 2001): 223. http://dx.doi.org/10.1016/s0378-5173(01)00823-7.

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Peppas, Nicholas A. "Transport Processes in Pharmaceutical Systems." Journal of Controlled Release 71, no. 2 (April 2001): 213. http://dx.doi.org/10.1016/s0168-3659(01)00238-3.

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Dissertations / Theses on the topic "Pharmaceutical processes"

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Scarr, James Richard Hadley. "Pharmaceutical development processes." Thesis, University College London (University of London), 2008. http://discovery.ucl.ac.uk/1446773/.

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The process of developing pharmaceuticals requires expertise from numerous different scientific areas. Four separate studies have been undertaken on Pharmaceuticals Testing, Process Development, Business Strategy and Process Validation within this industry. New pharmaceuticals generally require multi-step reactions, which increasingly feature the involvement of biological synthesis to improve the optical purity and thus efficacy and safety of the drug. Two of the problems with employing biological synthesis are the high level of inhibition observed and the potential difficulty with which these batch based reactions are combined with semi-continuous chemical synthesis. The first study characterises the inhibition of CHMO, a promising oxygenase enzyme, with the aid of flow cytometry using different systems: o A range of substrates, based around the natural substrate cyclohexanone but with differing ring size and increasing chain length. o Different CHMO catalysed reactions - isolated enzyme, free cell and immobilised whole cell. As expected, reactions with CHMO expressed in E. coli TOP 10 [pQR239] in their immobilised form reduced the observed reaction rate. Unexpectedly, for the more rapidly converted substrates (generally those closest to cyclohexanone), immobilisation was found to increase the inhibition observed. It has been postulated that this is due to an oxygen shortage for maintaining cell metabolism and a time based inhibitory effect. Advantages of immobilised cells are that they can be rapidly removed from the reaction broth allowing greater integration with other processes and can be recycled for multiple re-use. To facilitate their industrial use, the large scale production of immobilised whole cells is required. Whilst immobilised cell reactions are industrially employed, how such large quantities of immobilised cells are produced is yet to be reported. The feasibility of immobilisation of oxygenase expressing cells has been assessed in this first study, using the flow cytometry as a tool for assessing cell damage in the key step of cell separation. Within the pharmaceutical development process drug molecules are rigorously tested in clinical trials. However the metabolites likely to be produced in the body, which may be active (and preferable drug candidates to the parent molecule) or toxic (and thus responsible for the failure of the drug in the final stages of clinical trials) are often ignored. Within the human body the oxygenase enzymes Cytochrome P450s (CYPs) are responsible for the primary metabolism of more than 90% of drugs. The second study assesses different methods of identifying the CYP responsible for metabolism and discusses the importance of being able to produce gram scale quantities of metabolites. This study indicated that the best currently feasible option of CYP identification is the employment of Bactosome (individual CYP enzymes expressed in bacteria) with a selective inhibitor pre-screen. The scientific complexity of the pharmaceutical development process makes effective strategic planning and decision making difficult. Whilst the necessity of business plans to enable companies to secure finance has helped scientists to gain an understanding of their market and associated business risks, business decisions such as when to invest and how much, often rely solely on the company's tolerance of risk, collective intuition and experience. The third study investigates the business strategy of the pharmaceutical development process. StrategyDynamics modelling has been employed to create a living model of a start-up contract research organisation. The model demonstrates the advantages of being able to predict key resource bottlenecks, contrast different business decisions such as growth strategy and plan for future events and changes in technology and markets. This modelling can potentially save companies from expensive trial and error approaches and help to manage risk. Regulatory pressure within the pharmaceutical development industry and the importance of validation is increasing. In the fourth study the application of Process Validation to the areas of pharmaceutical development process in the first three studies are investigated. For CHMO biocatalysis the reproducibility of immobilised experiments was assessed, for drug metabolite production the importance of change validation, i.e. assay robustness, was determined and for the Strategy Dynamics modelling an approach to validating the model has been detailed.
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Hussain, M. S. H. "Magnesium stearate lubrication in pharmaceutical processes." Thesis, University of Bradford, 1988. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.233659.

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Johnson, David Benjamin. "Integrated design under uncertainty for pharmaceutical processes." Thesis, University College London (University of London), 2003. http://discovery.ucl.ac.uk/1383052/.

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in pharmaceutical process development there is frequently a large element of process uncertainty since knowledge of the mechanisms of production and separation is often limited. The overall objective of this thesis is the development of a general methodology which combines process modelling with uncertainty techniques to support the process development of complete integrated sequences. In a structured approach the uncertainty can be managed and improved process performance may be obtained. The major concept of this work is the integration of stochastic methods into a general framework for batch and continuous process models, consisting of two main parts. The first combines systematic modelling procedures with Hammersley sampling based Uncertainty Analysis and a range of sample-based Sensitivity Analysis techniques, used to quantify predicted performance uncertainty and identify key uncertainty contributions. In the second, a stochastic optimisation approach is employed to solve different problems under uncertainty. The methodology was implemented on two case studies. The first study investigated a batch reactor process. Some undesirable performance characteristics were observed when the published nominal optimal isothermal operating policy was implemented in the uncertain system. It was found that a robust operating policy significantly improved the total process time characteristic but not the impurity content and an alternative non-isothermal policy strategy would be a better option. The second study investigated a complete process sequence. As models developed with incoming data, uncertainty in the reaction and crystallisation parameters were critical to the endpoint quality criteria. Expected performance was improved by considering the propagation of uncertainty in the complete process. Four different flowsheets were compared, considering profitability and control tolerance criteria under uncertainty. The case study results indicate the importance in considering uncertainty systematically and quantitatively when conventional modelling techniques are employed. The methodology showed the opportunity to improve process performance potential and provide more realistic information to support pharmaceutical process development.
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Ricard, Francois-Xavier. "Application of electrical resistance tomography to pharmaceutical processes." Thesis, Imperial College London, 2005. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.417797.

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Zolotariov, Eyal. "Modelling and optimisation of pharmaceutical formulations and processes." Thesis, King's College London (University of London), 2001. https://kclpure.kcl.ac.uk/portal/en/theses/modelling-and-optimisation-of-pharmaceutical-formulations-and-processes(0bc4835e-7920-4bca-9f87-f816770704ac).html.

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HAUSMAN-MANNING, DEBRA SUE. "APPLICATION OF PROCESS ANALYTICAL TECHNOLOGY TO PHARMACEUTICAL PROCESSES." University of Cincinnati / OhioLINK, 2005. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1108838053.

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Muller, Damian Christian. "Investigating the influences of validation on pharmaceutical manufacturing processes." Thesis, Nelson Mandela Metropolitan University, 2007. http://hdl.handle.net/10948/566.

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This investigation attempts to examine the influences of validation on pharmaceutical processes especially at a new manufacturing facility that has to meet international requirements, and fulfil a cost effective business strategy. At Aspen Pharmacare, a pharmaceutical organisation, there are two manufacturing facilities situated adjacent to each other, one new and one old. The new facility creates ideal opportunities to supply products to local and international markets. The investigation compares legal requirements from local and international regulatory authorities. Validation and qualification practices as well as the problems encountered during the different phases are discussed. Particular attention is given to the validation approach at the new Aspen facility. Problems and proposed solutions relating to the design review, installation, operational, and performance qualification are discussed. Validation of analytical methods for cleaning analysis, cleaning validation of equipment, and optimisation of some tablet manufacturing processes are described. Statistical evaluations of analytical results are included to find the optimum conditions for integrating new personnel with new processes and equipment. A business model reviews the cost of non-conformances of the enalapril maleate 10 mg tablets manufactured at the two manufacturing facilities. Finally the dissertation proves that validation is not only a regulatory requirement but that it also provides benefits such as adding value to the business, and ultimately reducing the cost of medicines.
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Burke, Keeley. "The use of statistics in understanding pharmaceutical manufacturing processes." Thesis, University of Newcastle upon Tyne, 2016. http://hdl.handle.net/10443/3096.

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Industrial manufacturing processes for pharmaceutical products require a high level of understanding and control to demonstrate that the final product will be of the required quality to be taken by the patient. A large amount of data is typically collected throughout manufacture from sensors located around reaction vessels. This data has the potential to provide a significant amount of information about the variation inherent within the process and how it impacts on product quality. However to make use of the data, appropriate statistical methods are required to extract the information that is contained. Industrial process data presents a number of challenges, including large quantities, variable sampling rates, process noise and non-linear relationships. The aim of this thesis is to investigate, develop and apply statistical methodologies to data collected from the manufacture of active pharmaceutical ingredients (API), to increase the level of process and product understanding and to identify potential areas for improvement. Individual case studies are presented of investigations into API manufacture. The first considers prediction methods to estimate the drying times of a batch process using data collected early in the process. Good predictions were achieved by selecting a small number of variables as inputs, rather than data collected throughout the process. A further study considers the particle size distribution (PSD) of a product. Multivariate analysis techniques proved efficient at summarising the PSD data, to provide an understanding of the sources of variation and highlight the difference between two processing plants. Process capability indices (PCIs) are an informative tool to estimate the risk of a process failing a specification limit. PCIs are assessed and developed to be applied to data that does not follow a standard normal distribution. Calculating the capability from the percentiles of the data or the proportion of data outside of the specification limits has the potential to generate information about the capability of the process. Finally, the application of Bayesian statistical methods in pharmaceutical process development are investigated, including experimental design, process validation and process capability. A novel Bayesian method is developed to sequentially calculate the process capability when data is collected in blocks over time, thereby reducing the level of noise caused by small sample sizes.
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Beyer, Andreas [Verfasser], and Claudia [Akademischer Betreuer] Leopold. "Solid state transformations during pharmaceutical processes / Andreas Beyer ; Betreuer: Claudia Leopold." Hamburg : Staats- und Universitätsbibliothek Hamburg, 2020. http://d-nb.info/120967601X/34.

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Tumuluri, Venkat S. "Quantitation of pharmaceutical formulations and monitoring of pharmaceutical processes using process analytical technology techniques : near infrared and Raman spectroscopy /." Full text available from ProQuest UM Digital Dissertations, 2007. http://0-proquest.umi.com.umiss.lib.olemiss.edu/pqdweb?index=0&did=1414121171&SrchMode=1&sid=7&Fmt=2&VInst=PROD&VType=PQD&RQT=309&VName=PQD&TS=1220637804&clientId=22256.

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Books on the topic "Pharmaceutical processes"

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Fytopoulos, Antonios, Rohit Ramachandran, and Panos M. Pardalos, eds. Optimization of Pharmaceutical Processes. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6.

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Pagani, M. F. M. BPEO for batch pharmaceutical processes. Manchester: UMIST, 1996.

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Talevi, Alan, and Pablo A. M. Quiroga, eds. ADME Processes in Pharmaceutical Sciences. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-99593-9.

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Agalloco, James, Phil DeSantis, Anthony Grilli, and Anthony Pavell. Handbook of Validation in Pharmaceutical Processes. 4th ed. Boca Raton: CRC Press, 2021. http://dx.doi.org/10.1201/9781003163138.

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Shioiri, Takayuki, Kunisuke Izawa, and Toshiro Konoike. Pharmaceutical process chemistry. Weinheim, Germany: Wiley-VCH, 2011.

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Li, Jie Jack, and E. J. Corey. Drug discovery: Practices, processes, and perspectives. Hoboken, N.J: John Wiley & Sons, 2013.

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1946-, Levin Michael, ed. Pharmaceutical process scale-up. 2nd ed. New York: Taylor & Francis, 2006.

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Wylie, McVay D., ed. Pharmaceutical process design and management. Farnham, Surrey: Gower, 2011.

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1946-, Levin Michael, ed. Pharmaceutical process scale-up. New York: Marcel Dekker, 2002.

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Fred, Nagelkerke J., Dierendonck Jan Hein van, and Noteborn Mathieu H. M, eds. Pharmaceutical intervention in apoptotic pathways. Amsterdam: North-Holland Publishers, 1998.

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Book chapters on the topic "Pharmaceutical processes"

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Wood, Richard T. "Fundamentals of Thermal Sterilization Processes." In Pharmaceutical Biotechnology, 191–212. Boston, MA: Springer US, 2002. http://dx.doi.org/10.1007/978-1-4615-0549-5_4.

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Hickey, Anthony J., and Stefano Giovagnoli. "Biopharmaceutical Processes." In AAPS Introductions in the Pharmaceutical Sciences, 73–80. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-91220-2_9.

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Laky, Daniel J., Daniel Casas-Orozco, Francesco Destro, Massimiliano Barolo, Gintaras V. Reklaitis, and Zoltan K. Nagy. "Integrated Synthesis, Crystallization, Filtration, and Drying of Active Pharmaceutical Ingredients: A Model-Based Digital Design Framework for Process Optimization and Control." In Optimization of Pharmaceutical Processes, 253–87. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_10.

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Matsunami, Kensaku, Sara Badr, and Hirokazu Sugiyama. "Design Framework and Tools for Solid Drug Product Manufacturing Processes." In Optimization of Pharmaceutical Processes, 393–412. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_15.

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Boojari, Mohammad Amin, Simone Perra, Giorgio Colombo, Matteo Grossi, Mark Nicholas Jones, Isuru Udugama, Morteza Nikkhah Nasab, et al. "Dynamic Modeling and Control of a Continuous Biopharmaceutical Manufacturing Plant." In Optimization of Pharmaceutical Processes, 323–53. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_12.

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Misra, Shamik, and Christos T. Maravelias. "Overview of Scheduling Methods for Pharmaceutical Production." In Optimization of Pharmaceutical Processes, 355–71. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_13.

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Das, Ashok, and Jitendra Kumar. "Mathematical Modeling of Different Breakage PBE Kernels Using Monte Carlo Simulation Results." In Optimization of Pharmaceutical Processes, 79–101. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-90924-6_4.

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Sarode, Chinmayee, Yashraj Jagtap, and Parag Gogate. "Ultrasound for Improved Encapsulation and Crystallization with Focus on Pharmaceutical Applications." In Optimization of Pharmaceutical Processes, 193–229. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_8.

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Stauffer, Fanny, Pierre-François Chavez, Julie Fahier, Corentin Larcy, Mehrdad Pasha, and Gabrielle Pilcer. "Challenges and Solutions in Drug Product Process Development from a Material Science Perspective." In Optimization of Pharmaceutical Processes, 413–35. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_16.

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Zhu, Xiaoxiang, Lifang Zhou, and Richard D. Braatz. "Method of Characteristics for the Efficient Simulation of Population Balance Models." In Optimization of Pharmaceutical Processes, 33–51. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-90924-6_2.

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Conference papers on the topic "Pharmaceutical processes"

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Boetker, Johan, Georg Scharrer, Johannes Khinast, Søren Soegaard, Joergen Garnaes, Jørn Sonnergaard, and Jukka Rantanen. "Towards simulation of compaction processes." In The 2nd Electronic Conference on Pharmaceutical Sciences. Basel, Switzerland: MDPI, 2012. http://dx.doi.org/10.3390/ecps2012-00810.

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Maga, Iulian O. "A monitoring system for contaminated pharmaceutical processes." In 2008 IEEE International Conference on Automation, Quality and Testing, Robotics. IEEE, 2008. http://dx.doi.org/10.1109/aqtr.2008.4588926.

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Jo, J., and J. Jungr. "P1AP.11 - Online Copper Monitoring for Pharmaceutical Processes." In 17th International Meeting on Chemical Sensors - IMCS 2018. AMA Service GmbH, Von-Münchhausen-Str. 49, 31515 Wunstorf, Germany, 2018. http://dx.doi.org/10.5162/imcs2018/p1ap.11.

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Yang, Wuqiang, and Haigang Wang. "Application of electrical capacitance tomography in pharmaceutical manufacturing processes." In 2019 IEEE International Instrumentation and Measurement Technology Conference (I2MTC). IEEE, 2019. http://dx.doi.org/10.1109/i2mtc.2019.8826945.

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Lee, Jin-Shyan, and Yuan-Ming Wang. "Model construction of pharmaceutical manufacturing processes using Petri nets." In 2011 6th IEEE Conference on Industrial Electronics and Applications (ICIEA). IEEE, 2011. http://dx.doi.org/10.1109/iciea.2011.5975798.

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Solodilov, A. A., A. Y. Voloshko, E. M. Kisil, K. A. Kudin, V. L. Samoilov, D. S. Soronov, and O. V. Shishkin. "Automation of processes of vacuum microwave drying the pharmaceutical products." In 2005 15th International Crimean Conference Microwave and Telecommunication Technology. IEEE, 2005. http://dx.doi.org/10.1109/crmico.2005.1565149.

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Lember, Erki, Karin Pachel, and Enn Loigu. "Adsorption of Diclofenac, Sulfamethoxazole and Levofloxacin with Powdered Activated Carbon." In Environmental Engineering. VGTU Technika, 2017. http://dx.doi.org/10.3846/enviro.2017.082.

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The presence of pharmaceutical residues in the receiving waterbodies of wastewater treatment plants (WWTP) and in the environment has become a global concern. We can now say for certain that, having metabolised in our bodies, partially modified or unmodified pharmaceuticals will reach WWTP. However, WWTP are not designed for the removal of such com-pounds. Only a small fraction of pharmaceuticals decompose during biological treatment or are adsorbed in sediment. There-fore, it is essential to find a treatment process that is capable of removing pharmaceutical residues. The aim of the present study was to research the removal of three pharmaceuticals found in the environment, namely diclofenac (DCF), sulfamethoxazole (SMX) and levofloxacin (LFX), through the use of powdered activated carbon (PAC). To this end, adsorption tests were con-ducted where the adsorption capacity was estimated according to the adsorbent dose and the residence time of the process. LFX had the highest adsorption rate: the removal effectiveness was 77% in a residence time of 5 minutes and in 60 minutes a stable indicator was achieved whereby 94% of LFX had become adsorbed. The worst adsorption property was observed for SMX, as 68% of SMX was adsorbed in a residence time of 60 minutes. According to the conducted tests, the Freundlich adsorption isotherms and constants characterising the adsorption were found where the DCF K was 23.8, the SMX K was 34.3 and the LFX K was 106.1. This test demonstrated that the pharmaceuticals selected for the experiment could easily be subjected to adsorption processes and could be removed by means of PAC.
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Benjamin, Wong Chee Keong. "Self-recognition of DNA — From life processes to DNA computation." In 2009 International Conference on Biomedical and Pharmaceutical Engineering (ICBPE). IEEE, 2009. http://dx.doi.org/10.1109/icbpe.2009.5384112.

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Kemp, Ian C., Alex Van Millingen, Houda Khaled, and Lewis Iler. "Simultaneous wetting and drying; fluid bed granulation and tablet film coating." In 21st International Drying Symposium. Valencia: Universitat Politècnica València, 2018. http://dx.doi.org/10.4995/ids2018.2018.7931.

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Simultaneous wetting and drying occur in processes such as fluid bed (top spray) granulation, Wurster coating and tablet film coating. This gives control challenges, as the spraying and evaporation processes must be carefully balanced and the operating window is significantly narrower than for standalone drying processes. Significant recent advances in modelling have led to effective scale-up and operational strategies. Factors such as flow cessation during filter bag shaking can have a major effect. A design space can be predicted which is often non-orthogonal, and pharmaceutical regulatory authorities have accepted filing submissions using a design space justified by mechanistic modelling. Keywords: pharmaceuticals; peak moisture content; bed temperature; conduction; design space.
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Van der Vorst, G., W. Aelterman, P. Van Broeck, S. Walraedt, K. Schaerlaekens, P. Stouthuyzen, H. Van Langenhove, and J. Dewulf. "Comparison of two pharmaceutical production processes using different eco-efficiency measuring methods." In SUSTAINABLE CHEMISTRY 2011. Southampton, UK: WIT Press, 2011. http://dx.doi.org/10.2495/chem110021.

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Reports on the topic "Pharmaceutical processes"

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Hooks, Daniel E., John D. Yeager, and Kyle J. Ramos. Constituent properties, process, and formulation effects contributing to functional characteristics in pharmaceutical and explosive composites. Office of Scientific and Technical Information (OSTI), June 2013. http://dx.doi.org/10.2172/1083097.

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Munhuweyi, Ngonidzashe Portia, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Resource Modelling for the QC Laboratory at XYZ Pharmaceuticals in Southern Africa. Purdue University, November 2021. http://dx.doi.org/10.5703/1288284317431.

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Quality control (QC) laboratories are critical components in drug manufacturing and running them efficiently contributes to better, consistent supply of cost-effective quality products, while also and preventing deaths due to untimely delivery or unavailability of medicines. Having a resource modelling tool to estimate resources needed to handle a particular demand in a given system is essential for efficient running of QC laboratory. This study was done to establish such a model at XYZ Pharmaceuticals. The list of all products manufactured by XYZ Pharmaceuticals Southern Africa was reviewed; and product families for all products were identified. Analysts’ hands on time (HOT) to process one sample of each of the product families was estimated. The number of analysts required to support the workload at XYZ Pharmaceuticals was calculated using the HOTs for the different product families and the Maslaton’s Calculation Model. A baseline resource model was established.
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Dickman, Martin B., and Oded Yarden. Regulation of Early Events in Hyphal Elongation, Branching and Differentiation of Filamentous Fungi. United States Department of Agriculture, 2000. http://dx.doi.org/10.32747/2000.7580674.bard.

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In filamentous fungi, hyphal elongation, branching and morphogenesis are in many cases the key to successful saprophytic and pathogenic fungal proliferation. The understanding of the fungal morphogenetic response to environmental cues is in its infancy. Studies concerning the regulation of fungal growth and development (some of which have been obtained by the participating collaborators in this project) point to the fact that ser/thr protein kinases and phosphatases are (i) involved in the regulation of such processes and (ii) share common structural and functional features between saprophytes and pathogens. It is our objective to combine a pharmaceutical and a genetic approach in order to identify, characterize and functionally dissect some of the regulatory factors involved in hyphal growth, branching and differentiation. Using an immunohistochemical approach, a ser/thr protein kinase involved in hyphal elongation in both Neurospora crassa and Colletotrichum trifolii has been localized in order to identify the physical arena of regulation of hyphal elongation. The analysis of additional kinases and phosphatases (e.g. Protein kinase C, cAMP-dependent kinase, lipid-activated protein kinase, components of the type 2A protein phosphatase) as well as a RAS-related gene (an additional key participant in signal transduction) has been performed. In order to succeed in advancing the goals of this project, we have taken advantage of available elongation/branching mutants in N. crassa and continuously combined the accumulated information obtained while studying the two systems in order to dissect the elements involved in these processes. The various inhibitors/effectors analyzed can serve as a basis for modification to be used as anti-fungal compounds. Understanding the regulation of hyphal proliferation is a key requirement for identifying novel target points for either curbing fungal growth (as in the case of pathogenesis) or affecting growth patterns in various biotechnological processes. The major objective of our joint project was to advance our understanding of regulation of hyphal growth, especially during early events of fungal germination. Towards achieving this goal, we have coupled the analysis of a genetically tractable organism (N. crassa) with a plant pathogen o economic importance (C. trifolii). As the project progressed we believe that the results obtained have provided a reinforcement to our basic approach which called for combining the two fungal systems for a joint research project. On the one hand, we feel that much of the advance made was possible due to the amenability of N. crassa to genetic manipulations. The relevance of some of the initial findings obtained in Neurospora have been proven to be relevant to the plant pathogen while unique features of the pathogen have been identified in Colletotrichum. Most of the results obtained from this research project have been published. Thus, the main volume of this report is comprised of the relevant publications describing the research and results obtained.
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Litvinova, Tatiana Mikhailovna, Evgeniia Alekseevna Budenkova, Liudmila Ivanovna Babaskina, Dmitrii Vladimirovich Babaskin, Irina Iurevna Glazkova, Olga Valerevna Krylova, and Irina Igorevna Galuzina. Methodological recommendations for the implementation of a marketing model of the development process and the formation of professional competencies in higher pharmaceutical education. OFERNIO, January 2022. http://dx.doi.org/10.12731/er0526.17012022.

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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part I. Institute of Validation Technology, July 2006. http://dx.doi.org/10.1080/21506590.wp7132006agko-rmsdfrbq.

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A risk management solution is described that is designed to facilitate risk-based qualification, validation, and change control activities within GMP and regulatory compliance environments in the EU. This solution is based upon a set of pre-defined, fundamental principles and design criteria, which were considered important. It offers a documented and ready-to-use ten-step process for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes.
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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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Borch, Thomas, Yitzhak Hadar, and Tamara Polubesova. Environmental fate of antiepileptic drugs and their metabolites: Biodegradation, complexation, and photodegradation. United States Department of Agriculture, January 2012. http://dx.doi.org/10.32747/2012.7597927.bard.

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Many pharmaceutical compounds are active at very low doses, and a portion of them regularly enters municipal sewage systems and wastewater-treatment plants following use, where they often do not fully degrade. Two such compounds, CBZ and LTG, have been detected in wastewater effluents, surface waters, drinking water, and irrigation water, where they pose a risk to the environment and the food supply. These compounds are expected to interact with organic matter in the environment, but little is known about the effect of such interactions on their environmental fate and transport. The original objectives of our research, as defined in the approved proposal, were to: Determine the rates, mechanisms and products of photodegradation of LTG, CBZ and selected metabolites in waters exposed to near UV light, and the influence of DOM type and binding processes on photodegradation. Determine the potential and pathways for biodegradation of LTG, CBZ and selected metabolites using a white rot fungus (Pleurotusostreatus) and ADP, and reveal the effect of DOM complexation on these processes. Reveal the major mechanisms of binding of LTG, CBZ and selected metabolites to DOM and soil in the presence of DOM, and evaluate the effect of this binding on their photodegradation and/or biodegradation. We determined that LTG undergoes relatively slow photodegradation when exposed to UV light, and that pH affects each of LTG’s ability to absorb UV light, the efficiency of the resulting reaction, and the identities of LTG’sphotoproducts (t½ = 230 to 500 h during summer at latitude 40 °N). We observed that LTG’sphotodegradation is enhanced in the presence of DOM, and hypothesized that LTG undergoes direct reactions with DOM components through nucleophilic substitution reactions. In combination, these data suggest that LTG’s fate and transport in surface waters are controlled by environmental conditions that vary with time and location, potentially affecting the environment and irrigation waters. We determined that P. ostreatusgrows faster in a rich liquid medium (glucose peptone) than on a natural lignocellulosic substrate (cotton stalks) under SSF conditions, but that the overall CBZ removal rate was similar in both media. Different and more varied transformation products formed in the solid state culture, and we hypothesized that CBZ degradation would proceed further when P. ostreatusand the ᵉⁿᶻʸᵐᵃᵗⁱᶜ ᵖʳᵒᶠⁱˡᵉ ʷᵉʳᵉ ᵗᵘⁿᵉᵈ ᵗᵒ ˡⁱᵍⁿⁱⁿ ᵈᵉᵍʳᵃᵈᵃᵗⁱᵒⁿ. ᵂᵉ ᵒᵇˢᵉʳᵛᵉᵈ ¹⁴C⁻Cᴼ2 ʳᵉˡᵉᵃˢᵉ ʷʰᵉⁿ ¹⁴C⁻ᶜᵃʳᵇᵒⁿʸˡ⁻ labeled CBZ was used as the substrate in the solid state culture (17.4% of the initial radioactivity after 63 days of incubation), but could not conclude that mineralization had occurred. In comparison, we determined that LTG does not degrade in agricultural soils irrigated with treated wastewater, but that P. ostreatusremoves up to 70% of LTG in a glucose peptone medium. We detected various metabolites, including N-oxides and glycosides, but are still working to determine the degradation pathway. In combination, these data suggest that P. ostreatuscould be an innovative and effective tool for CBZ and LTG remediation in the environment and in wastewater used for irrigation. In batch experiments, we determined that the sorption of LTG, CBZ and selected metabolites to agricultural soils was governed mainly by SOM levels. In lysimeter experiments, we also observed LTG and CBZ accumulation in top soil layers enriched with organic matter. However, we detected CBZ and one of its metabolites in rain-fed wheat previously irrigated with treated wastewater, suggesting that their sorption was reversible, and indicating the potential for plant uptake and leaching. Finally, we used macroscale analyses (including adsorption/desorption trials and resin-based separations) with molecular- level characterization by FT-ICR MS to demonstrate the adsorptive fractionation of DOM from composted biosolids by mineral soil. This suggests that changes in soil and organic matter types will influence the extent of LTG and CBZ sorption to agricultural soils, as well as the potential for plant uptake and leaching.
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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part II. Institute of Validation Technology, July 2006. http://dx.doi.org/10.1080/21506590.wp7142006agko-rmsdii.

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highlight the need for patient-focused and value-adding qualification, validation, and change control programmes for manufacturing and regulating medicinal products in the EU, which are cost-effective and in-line with current regulatory requirements and guidance. To this end, a formal risk management solution was presented that seeks to demonstrate, in a practical way, how Regulators and Industry in the EU may achieve these goals. This solution represents a formal and rigorous approach to risk management, offering a scientific and practical means for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes. Based on a ten-step, systematic process, this approach offers a ready-to-use and documented risk management methodology for these activities. This tool is not intended for use in all situations, or to address all risk areas or concerns encountered in GMP and Regulatory Compliance environments. Rather, its use should be commensurate with the complexity and/or criticality of the issue to be addressed, and in many instances, and in-line with ICH Q9 principles, a more informal approach to risk management may be more useful, and indeed proportionate.
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Zhang, Cheng, and Yue Yang. Impact of adaptive design on reducing the duration of clinical trials in rare cancers: a meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, February 2022. http://dx.doi.org/10.37766/inplasy2022.2.0081.

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Review question / Objective: Whether the application of adaptive design in clinical trials of rare cancers can shorten the duration of clinical trials? Condition being studied: Currently, the development of innovative drug products (InMPs) for rare cancers faces many challenges, including the difficulty of enrolling sufficient numbers of patients from small and heterogeneous patient populations for clinical trials, and the significant risks of high financial investment, long development times and potential failure from a pharmaceutical company's perspective for rare cancer drugs due to limited knowledge of the natural history of the disease. Therefore, alternative approaches to clinical trial design are needed to conduct cost-effective, well-controlled analyses that can assess treatment effects in small, heterogeneous populations within shorter time frames. Adaptive trials, on the other hand, may be an effective solution to this problem. Adaptive clinical trials are designed to accelerate the clinical trial process by making predefined adjustments to key parameters through data accumulated at predefined time points during the trial without compromising the integrity and validity of the results.This study aims to examine the value of adaptive design in reducing the duration of clinical trials in rare cancers and encourage their wider implementation.
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Mbabzi, Kikundwa Emma. Standardisation of Staff Training to Increase Efficiency. Purdue University, November 2021. http://dx.doi.org/10.5703/1288284317427.

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In any industry or organization, personnel training is emphasized with reference to National Regulatory Authorities (NRAs) guidelines and other globally accepted guidelines. In spite of many refresher training programs, the pharmaceutical industry still faces significant variations in individual/ team efficiency and productivity. Individuals/teams given the same task, SOPs, environment and materials continue to produce significantly different results reflecting the possibility of operating on different sets of theoretical and practical information, which may stem from differing trainer, training program or training method. This study focused on using a standardized manual for training two teams A and B involved in vaccine production, as a tool to increase employee efficiency, productivity and quality, at a Livestock vaccine manufacturing company, with an objective to shorten the supply chain of vaccines (starting with Newcastle disease vaccine I-2 strain) to improve product quality, availability and affordability up to rural household level and back yard farmers. Baseline data was collected from four pre-training production batches and compared with data collected from three post-training production batches. The results showed that a tailored standardized training was effective in achieving the same level of efficiency, regardless of how late or soon the member joined the facility, and who conducted the training. The process of training staff, using a company tailored standardized manual, was shown to be successful within this company’s set up and could potentially be applied to other industries that are struggling with implementation of uniform information to their staff.
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