Автор: Baertschi S.W. Название: Pharmaceutical Stress Testing: Predicting Drug Degradation Издательство: Taylor & Francis Год: 2005 ISBN: 978-0849359194 Серия: Drugs and the Pharmaceutical Sciences (Book 153) Язык: English Формат: pdf Размер: 13,4 mb Страниц: 504
Stress testing has long been recognized as an important part of the drug development process. Recent efforts by the International Conference on Harmonization (ICH) with regard to impurities and photostability have brought an increased regulatory scrutiny of impurities, requiring identification and toxicological qualification at very low levels. Coupled with the fact that the pharmaceutical industry is making major efforts to reduce the time it takes to get products to market, the potential for stability and impurity “surprises” that affect the development timeline has increased dramatically.
Stress testing is the main tool that is used to predict stability problems, develop analytical methods, and identify degradation products/pathways. tally complex. Thus, this book seeks to be a practical and scientific guide which will, hopefully, stimulate new ideas and further development of the science.
New Drug Approval Process, 5th Edition Автор: Richard A. Guarino and Richard Guarino Название: New Drug Approval Process, 5th Edition Издательство: CRC Press Год: 2009 ISBN: 9781420088496;...
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Pharmaceutical Stress Testing: Predicting Drug Degradation 
