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.