The Science and Regulations of Naturally Derived Complex Drugs / AAPS Advances in the Pharmaceutical Sciences Series Bd.32 (PDF)
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This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products),while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.
Larry A. Walker is Director Emeritus of the National Center for Natural Products Research (NCNPR) at the University of Mississippi, having retired at the end of 2016 after 15 years as director. He has been a member of the faculty of the School of Pharmacy at Ole Miss for 37 years. He took his undergraduate pharmacy training at Mercer University (1975), and his doctorate in Pharmacology from Vanderbilt University School of Medicine in 1979, He has worked for much of his career on natural products drug discovery, pharmacology, toxicology and metabolism. Dr. Walker is a co-author of more than 200 papers in peer-reviewed journals in pharmacology, toxicology, and natural products discovery and development. He is a member of the American Society of Pharmacognosy, American Society of Pharmacology and Experimental Therapeutics, American Society of Microbiology, American Society of Tropical Medicine and Hygiene, American Association of Pharmaceutical Scientists. He has served on
- 2019, 1st ed. 2019, 331 Seiten, Englisch
- Herausgegeben: Ram Sasisekharan, Sau L. Lee, Amy Rosenberg, Larry A. Walker
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3030117510
- ISBN-13: 9783030117511
- Erscheinungsdatum: 23.04.2019
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