Pharmaceutical Stress Testing
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing, and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The second edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework.
"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?
