Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences) - Hardcover

Hardcover

ISBN 10: 0824740211 ISBN 13: 9780824740214

Publisher: CRC Press, 2005

Synopsis

The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

About this title

Review

"The authors and editor have done a superb job of combining the theoretical, chemical, and practical aspects of stress testing...the text is a 'must have' for those involved in stability testing."
―Drug Development and Industrial Pharmacy

"This excellent reference on pharmaceutical stress testing will serve its purpose well, especially for pharmaceutical product development scientists and for members of regulatory agencies who are actively involved in the drug review and approval process."
―Doody's Review Service

Synopsis

This book serves as a practical, scientific guide to pharmaceutical stress testing. Written by leading authorities in the field, this reference addresses topics pertaining to the further development of the science, as well as considers the chemistry of drug degradation, oxidative susceptibility testing, comparative stress stability studies, physical and chemical stability, photostability stress testing, and the use of microcalorimetry in drug stress testing. Short Contents

Edition details

• Publisher: CRC Press
• Publication date: 2005
• Language: English
• ISBN 10: 0824740211
• ISBN 13: 9780824740214
• Binding: Hardcover
• Edition number: 1
• Number of pages: 504
• Editor: Baertschi Steven W., Alsante Karen M., Reed Robert A.