Organic Chemistry of Drug Degradation
A clear understanding of the organic chemistry of drug degradation is essential for maintaining the stability, efficacy, and safety of a drug product throughout its shelf-life. During analytical method development, stability testing, and pharmaceutical manufacturing troubleshooting activities, one of the frequently occurring and usually challenging events is the identification of drug degradants and the understanding of drug degradation mechanisms and pathways. This book is written by a veteran who has first-hand experience in drug design and development, degradation mechanism studies, analytical development, and manufacturing process trouble…
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Produktdetails
- ISBN: 978-1-78262-563-6
- EAN: 9781782625636
- Produktnummer: 20501045
- Verlag: Royal Society of Chemistry
- Sprache: Englisch
- Erscheinungsjahr: 2015
- Seitenangabe: 306 S.
- Plattform: EPUB
- Masse: 16'845 KB
- Auflage: 1. Auflage
Über den Autor
Dr. Min Li is an Associate Director at Analytical Chemistry in Development and Supply - Supply Analytical Sciences Department of Merck & Co., Inc. He has led technical teams of senior-level scientists (Senior and Principal Scientists) for various analytical and pharmaceutical manufacturing process investigation and troubleshooting, impurity peak identification, study of drug degradation mechanisms, analytical method development, validation, specification setting, and support for new drug filing. He graduated from Fudan University and received his Ph.D. in Organic Chemistry from Johns Hopkins University, followed by a postdoctoral research at University of Illinois at Chicago in medicinal chemistry. Dr. Li was a Principal Scientist at Roche (1995 - 1998), a Scientific Fellow at Merck (1998 - 2005), and a manager at Schering-Plough (2005 - 2010). He was president of Sino-American Pharmaceutical Professionals Association (SAPA) between 2003 and 2004. Dr. Li is the first/primary author of more than 40 publications in a multi-disciplinary arena including organic, medicinal, bioconjugate, and analytical chemistry, as well as mass spectrometry. He has been invited to present in numerous international scientific meetings and conferences.
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