Relevant bibliographies by topics / Efficacy and quality of the drug product

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Efficacy and quality of the drug product'

Author: Grafiati
Published: 2 June 2025
Last updated: 31 July 2025

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Journal articles on the topic "Efficacy and quality of the drug product"

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Yamuna, Choudhary, Goyal Anju, and Vaishnav Rajat. "Process Validation of Solid Dosage Form." Pharmaceutical and Chemical Journal 7, no. 1 (2020): 46–54. https://doi.org/10.5281/zenodo.13952198.

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Process validation is an essential part for the safety of drug products and also to maintain the quality of the products. It is a fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to ensure the identity, purity, safety, and efficacy of drug products. The process validation precisely focused on the aim and method of analysis. The Process validation reduces product recalls and troubleshooting assignments which results in more economical manufacturing process and quality products. In this article an overview is given on
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Mannan, Abdul, and Hajera Mubeen. "DIGITALISATION AND AUTOMATION IN PHARMACEUTICALS FROM DRUG DISCOVERY TO DRUG ADMINISTRATION." International Journal of Pharmacy and Pharmaceutical Sciences 10, no. 6 (2018): 1. http://dx.doi.org/10.22159/ijpps.2018v10i6.24757.

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The rapid progress in the pharmaceutical industry is due to the advancement in the digitalization and automation starting from the invention to the administration of the drug. Every advancement in the development of the pharmaceutical product is associated with progress in digitalization. A drug or a drug product to be administered safely and to provide efficacy it has to undergo a long journey from its discovery, including pre-clinical and clinical trials to further product development in the research and development. The production and manufacturing systems with appropriate digitalization an
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Aziz-Andersen, Kaiser Jay. "Biosimilar Biologic Drugs: A Systematic Approach to Development, Manufacturing and Clinical Applications." Journal of Drug Delivery and Therapeutics 10, no. 6 (2020): 191–94. http://dx.doi.org/10.22270/jddt.v10i6.4373.

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This publication addresses biosimilar biologic drugs development and future innovations. Emphasis is placed on quality system approaches to the development and availability of new biosimilar drug products presented in premarket applications. For approvals of new biosimilars, the sponsors of premarket applications must present analytical and biological characterization to demonstrate that a proposed biosimilar drug is highly similar to the licensed reference product. The premarket application protocol requires a sponsor to describe the biosimilar product’s PK/PD clinical data comparing its safe
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Alkesh, S. Mourya, and Rajesh Kumar Pandey Dr. "A Study on Factors Attributed to Failure of Pharmaceutical Products." Applied Science and Biotechnology Journal for Advanced Research 3, no. 2 (2024): 12–21. https://doi.org/10.5281/zenodo.10976869.

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The Pharmaceutical Industry plays a pivotal role in healthcare by developing, manufacturing, and marketing drugs to treat a myriad of medical conditions. However, despite rigorous research, development, and testing processes, a significant number of pharmaceutical products fail to meet the expected standards or gain market acceptance. This study aims to explore the multifaceted factors that contribute to the failure of pharmaceutical products, focusing on the product life cycle as a framework for analysis. The product life cycle of a pharmaceutical product encompasses several stages, including
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Khan, Rana Muhammad Awais, and Mubashar Rehman. "Quality Determination (In-process & Finished product Quality Testing Parameters) of Triamcinolone Acetonide Injectable Suspension." Global Drug Design & Development Review III, no. I (2018): 23–30. http://dx.doi.org/10.31703/gdddr.2018(iii-i).04.

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Triamcinolone acetonide is an antiinflammatory drug that has been used for more than 50 years for the treatment of various inflammatory disorders including the arthritis & gout etc. Moreover, in recent years its use has been rapidly increased for the treatment of retinal vasculature disease and Uveitis, periocular and intraocular treatment. This review summarizes the whole manufacturing process of this formulation along with the complete in-process QC & Finished dosage form test parameters that ensures the efficacy and safety of this drug. Furthermore, the industrial requirements in th
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Swapnil, Khopade* Dr. Deepak Kardile Aniket Mohite Dr. Vishwas Bhagat Tushar Shinde Dr. Rajkumar Shete Vaibhavi Kunjir. "The Role of Stability-Indicating RP-HPLC In Ensuring Drug Product Quality and Shelf Life." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 3509–31. https://doi.org/10.5281/zenodo.15115168.

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Reverse-phase high-performance liquid chromatography (RP-HPLC) is commonly employed in pharmaceutical analysis for the isolation and quantification of drugs, impurities, and degradation products. Ensuring the quality of drug products and the shelf life—determined by the potency, safety, and efficacy of a particular drug—is an important assessment that is carried out through stability studies, where environmental variables such as temperature, humidity, and storage conditions are tested to see how they affect the drug over time. Stability-indicating RP-HPLC method is one o
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Ganesh, U. Chavan* Vitthal R. Gawade1 Vaibhav P. Chopade2 Shubham V. Wankhede Sahil D. Nivangune3 Dattatray B. Gatade4. "Review On Drug Stability." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 954–65. https://doi.org/10.5281/zenodo.11214813.

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This includes drug stability studies Important parameters for new drugs and new drug development pharmaceutical formulation. Durability prediction plays a big role All dosage forms and their drug development Helps determine and suggest storage conditions for each Label description. Ensuring drug stability research Maintain product quality, safety and effectiveness throughout Durability is a prerequisite for acceptance Drug approval. These studies are necessary It will be implemented according to the guidelines issued by ICH. WHO or other institution Stability is crucial to the process of devel
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Kishor, S. Arote* Darshan A. Salade Nilesh V. Patil. "A Brief Review on Regulatory Affairs: Ensuring Compliance, Safety, and Market Access." International Journal in Pharmaceutical Sciences 1, no. 10 (2023): 22–30. https://doi.org/10.5281/zenodo.8397986.

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This review paper provides a comprehensive analysis of the field of regulatory affairs, offering insights into its historical evolution, current challenges, emerging trends, and future directions. Regulatory affairs play a pivotal role across various industries in ensuring compliance with laws and regulations, maintaining product quality, and safeguarding public health and safety. Drug regulatory affairs are an important part of the pharmaceutical industry. As usual the pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry f
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Abdul Wadood Ansari, Arti, Ashish Kumar Yadav, Abhisek Yadav, Mohd Mushaid, and Tanya Singh. "Pharmaceutical packaging innovations: enhancing drug safety, efficacy, and patient compliance: A brief review." World Journal of Biology Pharmacy and Health Sciences 22, no. 3 (2025): 072–87. https://doi.org/10.30574/wjbphs.2025.22.3.0466.

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In the pharmaceutical sector, packaging plays a significant role in the development of different drug formulations. An essential component that protects the pharmaceutical substance is the packaging. Maintaining the quality of pharmaceuticals during storage, delivery, transit, and sale is dependent on the product's quality. Product containment, ease of use, and compliance during storage, transportation, display, and consumption. the stability of medicine solid, liquid, gel or paste form depend on packing material to prevent drug from chemical degradation. There are three levels of classificati
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Gogna, Kunal. "Regulatory aspects of Impurity profiling." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 45–54. http://dx.doi.org/10.22270/ijdra.v8i4.433.

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Quality, safety and efficacy of pharmaceuticals play an important role in drug therapy. The safety attribute of drug is established by its pharmacological or toxicological profile along with adverse effects caused by impurities in bulk and dosage form. Impurities present in drug often possess undesired pharmacological or toxicological effects which outweighs the benefits of drug therapy. Recently, many impurity cases have been reported for e.g. NDMA (N-nitroso dimethylamine) impurity in drug product Ranitidine. This may be due to inappropriate follow of impurity related regulatory guidelines o
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Dissertations / Theses on the topic "Efficacy and quality of the drug product"

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Rezende, Ricardo Leite de Oliveira. "Separação dos enatiômeros do cetoprofeno e do fenoprofeno por CLAE em fase estacionária quiral." Universidade de São Paulo, 2008. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-04022009-195023/.

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Durante muito tempo, os fármacos quirais de origem sintética foram comercializados predominantemente como racematos. Atualmente, sabe-se que os enantiômeros de um fármaco quiral podem apresentar propriedades farmacocinéticas, farmacodinâmicas e toxicológicas bastante distintas. Assim sendo, técnicas analíticas enantiosseletivas são fundamentais para a pesquisa e para o controle da qualidade desses fármacos. O cetoprofeno e o fenoprofeno são dois fármacos quirais, pertencentes à classe dos agentes antiinflamatórios não-esteróides derivados do ácido propiônico. Seus enantiômeros apresentam signi
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Braga, Gláucia Karime. "Identificação dos riscos sanitários na manipulação de medicamentos alopáticos não estéreis em farmácia comunitária e o papel das boas práticas de manipulação no controle desses riscos." Universidade de São Paulo, 2009. http://www.teses.usp.br/teses/disponiveis/60/60137/tde-19082009-122809/.

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A manipulação de medicamentos pode ser considerada a essência da profissão farmacêutica. Os produtos manipulados são destinados a um indivíduo e, por essa razão, eles são considerados uma importante ferramenta na terapêutica. Entretanto, de acordo com a literatura, a ausência de comprovação científica quanto à segurança e eficácia clínica desses medicamentos faz com que os profissionais de saúde assumam um risco toda vez que um medicamento manipulado é dispensado. Com a finalidade de regular esse setor, a ANVISA aprovou o Regulamento Técnico de Boas Práticas de Manipulação em Farmácia BPMF a
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YANG, CHIH-SHENG, and 楊至聖. "Optimize Drug Product Quality Review System-BFS Production Line." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/g4t2c3.

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碩士<br>銘傳大學<br>國際企業學系碩士在職專班<br>107<br>Annual Product Quality Review (APQR) is an evaluation which is prepared according to the Current Good Manufacture Practice (CGMP) requirements of different regulatory authorities. The Current Good Manufacturing Practice (CGMP) is designed to regulate pharmaceutical companies and require pharmaceutical companies has to producing safe and effective products which are consistently produced and controlled according to quality standards. APQRs not only are required by GMP but also required for robust quality improvement for manufacturing the pharmaceutical produ
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Tsai, Ho-Hsin, and 蔡和鑫. "The effects of relationship quality, perception of product innovation and the reimbursement on physician’s prescribing intention of new drug." Thesis, 2013. http://ndltd.ncl.edu.tw/handle/35674331155524869925.

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碩士<br>國立高雄應用科技大學<br>高階經營管理研究所碩士在職專班<br>101<br>The research results show that the relationship quality and perception of product innovation have significant effects on physician’s prescribing intention of new drug. The reimbursement of new drug moderates the effects of the perception of product innovation on physician’s prescribing intention of new drug. But it doesn’t moderate the effects of the relationship quality. We also find that the influences of the constructs, commitment, rewards and trust, of relationship quality on physician’s prescribing intention of new drug are significant. Howeve
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Silva, Ana Sofia Pereira da. "The influence of raw materials' attributes on the drug product performance of dry powder inhalers." Master's thesis, 2014. http://hdl.handle.net/10451/27955.

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Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2014<br>The present work describes the determination of the influence of specific raw material attributes on a drug product for inhalation performance. Each raw material (drug substance and sugar-based excipients) was characterized in terms of properties that can have an impact in the drug product formulation and performance, such as particle size distribution and dynamic powder properties. The formulations’ performance was determined through its aerodynamic particle size distribution (aPSD) by using a N
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McCanna, David. "Development of Sensitive In Vitro Assays to Assess the Ocular Toxicity Potential of Chemicals and Ophthalmic Products." Thesis, 2009. http://hdl.handle.net/10012/4338.

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The utilization of in vitro tests with a tiered testing strategy for detection of mild ocular irritants can reduce the use of animals for testing, provide mechanistic data on toxic effects, and reduce the uncertainty associated with dose selection for clinical trials. The first section of this thesis describes how in vitro methods can be used to improve the prediction of the toxicity of chemicals and ophthalmic products. The proper utilization of in vitro methods can accurately predict toxic threshold levels and reduce animal use in product development. Sections two, three and four describe t
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Books on the topic "Efficacy and quality of the drug product"

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1940-, Cartwright A. C., and Matthews Brian, eds. International pharmaceutical product registration: Aspects of quality, safety and efficacy. Ellis Horwood, 1994.

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Jameel, Feroz, Susan Hershenson, Mansoor A. Khan, and Sheryl Martin-Moe, eds. Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2316-8.

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Khan, Mansoor A., Feroz Jameel, Susan Hershenson, and Sheryl Martin-Moe. Quality by design for biopharmaceutical drug product development. Springer, 2015.

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1940-, Cartwright A. C., and Matthews Brian, eds. International pharmaceutical product registration. 2nd ed. Informa Healthcare, 2009.

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Great Britain. Medicines Control Agency., ed. Towards safe medicines: A guide to the control of safety, quality and efficacy of human medicines in the United Kingdom. HMSO, 1993.

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Quality, American Society for, ed. Data integrity and compliance: A primer for medical product manufacturers. ASQ Quality Press, 2019.

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Randall, Jonathan A. Issues and impacts of foreign pharmaceuticals. Nova Science, 2011.

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United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations. Counterfeit bulk drugs: Hearings before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Sixth Congress, second session, June 8 and October 3, 2000. U.S. G.P.O., 2000.

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R, Berndt Ernst, and National Bureau of Economic Research., eds. The roles of marketing, product quality and price competition in the growth and composition of the U.S. anti-ulcer drug industry. National Bureau of Economic Research, 1994.

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Office, General Accounting. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. U.S. General Accounting Office, 2001.

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Book chapters on the topic "Efficacy and quality of the drug product"

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Hoen, Ellen ‘t. "Protection of Clinical Test Data and Public Health: A Proposal to End the Stronghold of Data Exclusivity." In Access to Medicines and Vaccines. Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-83114-1_7.

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AbstractTest data demonstrating the efficacy, safety and quality of a medicine is required by drug regulatory agencies before a new treatment obtains marketing approval and can be made available to patients. Because test data can be costly and time-consuming to produce, certain countries have ‘data exclusivity’ regimes that restrict use of test data to the originator company for a period of time. Generic and biosimilar companies rely on originator test data to obtain marketing approval for generic products, so data exclusivity periods can delay entry of lower-cost treatments to the market. Whi
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Kristensen, Knud. "New Developments: Laboratory Facilities / Product Quality." In Safety and Efficacy of Radiopharmaceuticals 1987. Springer Netherlands, 1987. http://dx.doi.org/10.1007/978-94-009-3375-0_28.

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Singh, Dilip Kumar, and Saranjit Singh. "Drug Substance/Product Quality Analysis (Quality Assessment)." In The Quintessence of Basic and Clinical Research and Scientific Publishing. Springer Nature Singapore, 2023. http://dx.doi.org/10.1007/978-981-99-1284-1_11.

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Madhav, Hari, and Nasimul Hoda. "Antifungal Efficacy of Natural Product-Based Chemical Derivatives." In Advances in Antifungal Drug Development. Springer Nature Singapore, 2024. http://dx.doi.org/10.1007/978-981-97-5165-5_18.

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Gibson, Mark, Alan Carmody, and Roger Weaver. "Development and Manufacture of Drug Product." In Pharmaceutical Quality by Design. John Wiley & Sons, Ltd, 2018. http://dx.doi.org/10.1002/9781118895238.ch6.

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Doymaz, Fuat, Frank Ye, and Richard K. Burdick. "Product Homogeneity Assessment During Validation of Biopharmaceutical Drug Product Manufacturing Processes." In Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2316-8_26.

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Sayyed Sallam, Al, Sami Nazzal, Hatim S. AlKhatib, and Nabil Darwazeh. "Quality by Design: Concept for Product Development of Dry-powder Inhalers." In Pulmonary Drug Delivery. John Wiley & Sons, Ltd, 2015. http://dx.doi.org/10.1002/9781118799536.ch15.

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Lam, Philippe, Fredric J. Lim, and Samir U. Sane. "Drug Substance Frozen Storage and Thawing." In Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2316-8_9.

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Chang, Liuquan, Jeffrey T. Blue, Joseph Schaller, Lynn Phelan, Lakshmi Khandke, and Bruce A. Green. "Applicability of QbD for Vaccine Drug Product Development." In Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2316-8_19.

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Soni, Anshita Gupta, Renjil Joshi, Deependra Soni, Chanchal Deep Kaur, Swarnlata Saraf, and Pankaj Kumar Singh. "Quality Control and Evaluation of Synbiotics Nutraceutical Product." In Synbiotics in Human Health: Biology to Drug Delivery. Springer Nature Singapore, 2024. http://dx.doi.org/10.1007/978-981-99-5575-6_31.

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Conference papers on the topic "Efficacy and quality of the drug product"

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Cao, Xinyu, Yifan Song, Jiayuan Wang, Linyu Zhu, and Xi Chen. "Bayesian Optimization for Enhancing Spherical Crystallization Derived from Emulsions: A Case Study on Ibuprofen." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.158833.

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The pharmaceutical industry is a highly specialized field where strict quality control and accelerated time-to-market are essential for maintaining competitive advantage. Spherical crystallization has emerged as a promising approach in pharmaceutical manufacturing, offering significant potential to reduce equipment and operating costs, enhancing drug bioavailability, and facilitating compliance with product quality regulations. Emulsions, as an enabling technology for spherical crystallization, present unique advantages. However, the quality of spherical crystallization products derived from e
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Hernández, Juan F., Ridha H. Abbas, Saud A. Abudaly, Subhash Nair, and Sreenivas Km. "Biocide Selection Score Card: a Numerical Approach to Product Selection." In MECC 2023. AMPP, 2023. https://doi.org/10.5006/mecc2023-19919.

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Abstract Large volume of water used for hydrocarbon production and processing can be an ideal place for bacterial growth and survival. Presence of bacteria can affect the quality of the product, asset integrity and the overall safety of the operations. Therefore, it is important to have a well-defined microbial control program, involving mainly proactive approaches in control of microorganisms. Monitoring, using different detection techniques, and control, using appropriate biocide treatments, are important measures in the program. Different types of biocides are available for microbial contro
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Shahab, Mohammad, Kensaku Matsunami, Zoltan Nagy, and Gintaras Reklaitis. "Process analysis of end-to-end continuous pharmaceutical manufacturing using PharmaPy." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.154363.

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As pharmaceutical manufacturing is transitioning from traditional batch to continuous manufacturing (CM), there is a lack of tools for CM design and development, which can integrate drug substance and drug product unit operations for overall evaluation. Recently, a Python-based PharmaPy framework was proposed to advance the design, simulation, and analysis of continuous pharmaceutical processes. However, the initial library of models only addressed upstream drug substance processing. In this work, new capabilities, including drug product unit operations such as feeder, blender, and tablet pres
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Obeyesekere, Nihal, and Thusitha Wickramarachchi. "Transition from Combinatorial Chemistry to Present Day Robotics in Product Development for Oil Field Chemicals." In MECC 2023. AMPP, 2023. https://doi.org/10.5006/mecc2023-20245.

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Abstract In this paper, the slow evolution of combinatorial chemistry from its dawn in 1980’s to today’s oil field product development is discussed. Combinatorial chemistry comprises chemical synthetic methods that make it possible to prepare a vast number of compounds in a single process. These compound libraries can be made as mixtures, sets of individual compounds or chemical structures generated by computer software. This phenomenon was first invented by Arpad Furka (Lorand University, Budapest) in 1982. He described the principle of it, the combinatorial synthesis and a deconvolution proc
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Gao, Shang, and Brahim Benyahia. "Robust Techno-economic Analysis, Life Cycle Assessment, and Quality and Sustainability by Digital Design of Three Alternative Continuous Pharmaceutical Tablet Manufacturing Processes." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.104102.

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This study presents a comprehensive comparison of the three alternative downstream manufacturing technologies for pharmaceuticals: i) Dry Granulation (DG) through roller compaction, ii) Direct Compaction (DC), and iii) Wet Granulation (WG) based on the economic, environmental and product quality performances. Firstly, the integrated dynamic mathematical models of the different downstream (drug product) processes were developed using gPROMS formulated products based on data from the literature or/and our recent experimental work. The process models were developed and simulated to reliably captu
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Place, Trevor, Amanda Prefontaine, Jasmine Zhang, and Matthew McEachern. "Assessment of Corrosion Inhibitors for Very Light Hydrocarbon and Finished Product Pipelines." In CORROSION 2019. NACE International, 2019. https://doi.org/10.5006/c2019-13028.

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Abstract Over the past 15 years, increasing production of bitumen from oil sands operations has led to increased need for long distance transport of very light liquid hydrocarbons used as diluents. Over the same time frame, multistage fracking has led to dramatic increases in production of very light shale oils ("tight oil") having comparable physical properties to hydrocarbons used as diluents. These products typically contain very little water or dissolved gases - and hence are markedly similar to finished products such as motor fuels. Although these products are quite clean, the trace water
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Barhate, Yash, Daniel Casas-Orozco, Daniel J. Laky, Gintaras V. Reklaitis, and Zoltan K. Nagy. "Hybrid Rule-based and Optimization-driven Decision Framework for the Rapid Synthesis of End-to-End Optimal (E2EO) and Sustainable Pharmaceutical Manufacturing Flowsheets." In Foundations of Computer-Aided Process Design. PSE Press, 2024. http://dx.doi.org/10.69997/sct.115998.

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In this paper, a hybrid heuristic rule-based and deterministic optimization-driven process decision framework is presented for the analysis and optimization of process flowsheets for end-to-end optimal (E2E0) pharmaceutical manufacturing. The framework accommodates various operating modes, such as batch, semi-batch and continuous, for the different unit operations that implement each manufacturing step. To address the challenges associated with solving process synthesis problems using a simulation-optimization approach, heuristic-based process synthesis rules are employed to facilitate the red
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Batista, Daniel V., and Marco S. Reis. "Balancing modelling complexity and experimental effort for conducting QbD on lipid nanoparticles (LNPs) systems." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.163183.

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The promising properties of lipid nanoparticles (LNPs) as drug carriers have been attracting significant attention in the field of drug delivery. However, further research is still required for a better understanding of their integration in the pharmaceutical industry. The Quality by Design (QbD) approach aims at ensuring the safety and efficiency in the development of new drugs, through an holistic, risk-based approach that gathers all sources of knowledge available about the system under analysis. One key resource of the QbD framework is the rich toolkit of Design of Experiments (DOE), to de
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Keo, Van Dong, Xuan Tran Hiep, Quoc Nguyen Banh, Tran Anh Son, and Duong Huyen Lynh. "Determination of Geometrical Parameters to Balance the Pressure Drop of Channels on a Microfluidic Chip." In 2024 International Conference on Machining, Materials and Mechanical Technologies. Trans Tech Publications Ltd, 2025. https://doi.org/10.4028/p-me24oh.

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In the past few years, micro-droplets have been widely used in diverse fields of biological and chemical research, spanning from drug delivery and material synthesis to point-of-care diagnostics, digital PCR, and single-cell analysis. Droplet-based microfluidics offers a powerful platform for conducting complex experiments, screening processes, and analyses with enhanced precision, efficiency, and versatility. While creating droplets with uniform sizes is a common objective of microfluidics, it is not limited to producing droplets of a single size per chip. Creating microdroplets with differen
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Tasić, Tamara, Vedran Milanković, Christoph Unterweger, et al. "EFFICIENT CHLORPYRIFOS REMOVAL FROM WATER USING CELLULOSE-DERIVED POROUS CARBONS." In 8th Workshop Food and Drug Safety and Quality. Vinča Institute of Nuclear Sciences - National Institute of the Republic of Serbia, 2024. http://dx.doi.org/10.46793/8fdsq.pb16tt.

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The widespread use of the organophosphate pesticide chlorpyrifos, coupled with its acute neurotoxicity, underscores the urgent need for effective remediation strategies. Among the various methods explored for chlorpyrifos removal from water, adsorption has emerged as the most promising. We investigated the potential of two cellulose-derived porous carbons, produced via different activation strategies, as adsorbents for chlorpyrifos removal from water. The kinetics of batch adsorption fit well with both pseudo-first-order and pseudo-second-order models for both materials. Additionally, the Freu
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Reports on the topic "Efficacy and quality of the drug product"

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Ruxrungtham, Kiat, Vorapot Sapsirisavat, Vorasit Vongsutilers, et al. Pharmaceutical equivalence drugs assessment-I (PEDA-I) : assess the pharmaceutical equivalence of generic antiretrovirals distributed in Thailand : Final report. Chulalongkorn University, 2016. https://doi.org/10.58837/chula.res.2016.30.

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Objectives: Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. Methods: We sampled Tenofovir 300 mg, Efavirenz 600 mg and Lopinavir/ritonavir 200/50mg from 10 primary h
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Kwesiga, Victoria, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317428.

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With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active
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Berndt, Ernst, Linda Bui, David Reiley, and Glen Urban. The Roles of Marketing, Product Quality and Price Competition in the Growth and Composition of the U.S. Anti-Ulcer Drug Industry. National Bureau of Economic Research, 1994. http://dx.doi.org/10.3386/w4904.

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Apiyo, Eric, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Improving Pharmacovigilliance Quality Management System in the Pharmacy and Poisions Board of Kenya. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317444.

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The purpose of this study was to explore ways of improving the pharmacovigilance quality system employed by the Pharmacy and Poisons Board of Kenya. The Pharmacy and Poisons Board of Kenya employs a hybrid system of pharmacovigilance that utilizes an online system of reporting pharmacovigilance incidences and a physical system, where a yellow book is physically filled by the healthcare worker and sent to the Pharmacy and Poisons Board for onward processing. This system, even though it has been relatively effective compared to other systems employed in Africa, has one major flaw. It is a slow a
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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, 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;
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Feng, Ningning, Jianbin Guan, Xing Yu, et al. Jintiange Capsule May Have a Positive Effect in OVCF Patients with percutaneous vertebral augmentation: A Meta-Analysis of Randomized Trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2022. http://dx.doi.org/10.37766/inplasy2022.9.0038.

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Review question / Objective: We aimed to conduct a meta-analysis of the effects of JTG capsules on patients with OVCF underwent PVA surgery, focusing on clinical outcomes and drug safety. Condition being studied: This meta-analysis aims to systematic evaluation of clinical efficacy and adverse effects of JTG with PVA in the treatment of osteoporotic vertebral compression fracture (OVCF).Our current evidence suggests that JTG capsule may relieve pain in OVCF patients who underwent PVA surgery, improve functional activity, and increase BMD, particularly in patients under the age of 70, as well a
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Wu, Xiaoqi, Maoxia Fan, Yaobo Pan, and Dona Guo. Quality of Evidence Supporting the Effects of Ginkgo Terpene Lactone Preparations in Ischemic Stroke: An Overview of Systematic Reviews and Meta-Analyses. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2022. http://dx.doi.org/10.37766/inplasy2022.9.0124.

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Review question / Objective: 2.2.1 Type of studies SRs/MAs of Randomized Controlled Trials (RCTs) of GTLP for IS in any language. 2.2.2 Type of Participants Included patients were diagnosed with IS according to international or national standards, regardless of race, age, gender, time of onset, and source of cases. 2.2.3 Type of Intervention The intervention method in the control group was routine treatment, and the intervention method in the intervention group was GTLP treatment or GTLP combined with the treatment of the control group. 2.2.4 Types of outcomes Conclusions at least need to incl
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Gupta, Aditya, Tong Wang, Shruthi Ravi, Mesbah Talukder, Jessie Carviel, and Mary Bamimore. Relative efficacy of microneedling in the treatment of pattern hair loss: a protocol for a systematic review with network meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2022. http://dx.doi.org/10.37766/inplasy2022.9.0042.

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Review question / Objective: The objective of the proposed study is to determine the relative efficacy of microneedling and combination of it and other agents for androgenetic alopecia (AGA)—a condition that is also referred to as pattern hair loss. Rationale: Pattern hair loss is one of the most common forms of hair loss in men and women; the condition is associated with decreased quality of life. Oral finasteride and topical minoxidil are treatments currently approved, by the United States Food and Drug Administration, for AGA. However, finasteride has been associated with significant side e
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Usai, Jannet, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Herbal Medicines Registration Process for Zimbabwe Overview of the Process. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317434.

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Unregistered traditional medicines pose a huge public health threat as the safety and efficacy of these products is unknown. The issue this study addresses is the inadequate regulatory measures for herbal medicines in Zimbabwe. This project was done to describe the current registration process of traditional medicines in Zimbabwe, and to identify the gaps and opportunities they present to improve the regulatory landscape. Regulations and laws governing the registration of herbal medicines in the country and published research on legislation of herbal medicines were reviewed. Two parallel regul
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Gerstl, Zev, Thomas L. Potter, David Bosch, et al. Novel Herbicide Formulations for Conservation-Tillage. United States Department of Agriculture, 2009. http://dx.doi.org/10.32747/2009.7591736.bard.

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The overall objective of this study was to develop, optimize and evaluate novel formulations, which reduce herbicide leaching and enhance agronomic efficacy. Numerous studies have demonstrated that CsT promotes environmental quality and enhances sustainable crop production, yet continued use of CsT-practices appears threatened unless cost effective alternative weed control practices can be found. The problem is pressing in the southern portion of the Atlantic Coastal Plain region of the eastern USA where cotton and peanut are produced extensively. This research addressed needs of the region’s
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