Pharmaceutical Stress Testing: Predicting Drug Degradation
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.
“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
Pharmaceutical Stress Testing: Predicting Drug Degradation, 2nd Edition
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. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years.
Key features include:
- A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience.
- 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations
- Updated methodologies for predicting drug stability and degradation pathways
- Best practice models to follow
- An expanded Frequently Asked Questions section
This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).