This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book's internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.
This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book's internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.
In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself...
The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A...
Part B explores protein degradation occuring in vivo during protein synthesis in cells, examines the isolation and purification of proteins, details protein use in organisms, and reviews ...
Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs...
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