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).
Table of Contents
Steven W. Baertschi and Dan W. Reynolds
Stress Testing: A Predictive Tool
Steven W. Baertschi, Patrick J. Jansen, K.M. Alsante, Dan Reynolds and Biren Joshi
The Chemistry of Drug Degradation
Steven W. Baertschi, Karen M. Alsante and Dinos Santifianos
Stress Testing: Analytical Considerations
Patrick J. Jansen, W. Kimmer Smith, and Steven W. Baertschi
Relation to the Development Timeline
Steven W. Baertschi, Bernard A. Olsen, Karen M. Alsante and Robert A. Reed.
Oxidative Susceptibility Testing
Paul Harmon and Giovanni Boccardi
Photostability Stress Testing
Elisa Fasani and Angelo Albini
Practical Aspects of Conducting Photostability Stress Testing
David Clapham, Allen Templeton, Lee J. Klein, and Mark H. Kleinman
Role of 'Mass Balance' in Pharmaceutical Stress Testing
Mark A. Nussbaum, Patrick J. Jansen, Steven W. Baertschi, Andreas Kaerner, and Bernard A. Olsen.
Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening
Gregory A. Stephenson and Susan Reutzel-Edens
Solid-State Excipient Compatibility Testing
Amy S. Antipas, Margaret S. Landis, and Peter Wuelfing
Small Molecule Parenteral Drugs: Practical Aspects of Stress Testing
Andreas Abend, Brett Duersch, and Kyle Fiszlar
Stability Considerations in Development of Freeze Dried Pharmaceuticals
Steven L. Nail
Stress Testing of Therapeutic Monoclonal Antibodies
Michael R. DeFelippis, Bryan J. Harmon, Lihua Huang, and Muppalla Sukumar
Stress Testing of Oligonucleotides
Stress Testing to Determine Liposome Degradation Mechanisms
Patrick Ahl and Paul Meers
Stress Testing of Combination Therapies
Dan Reynolds and Biren Joshi
Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes or Materials from Multiple Sources
Bernard A. Olsen, Larry A. Larew, and Michael A. Watkins
Stress testing as a predictive tool for the assessment of potential genotoxic degradants
Christopher M. Riley, Dan Reynolds, Alan McKeown, Joel Bercu, Dave DeAntonis, Steve Baertschi, and Stephen Raillard
The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals
Thomas R. Sharp and Donald B. Boyd
Use of Automation in Conducting Stress Testing and Excipient Compatibility Studies
Chris Foti, Patrick Jansen, Eric Carlson
The Use of Microcalorimetry in Stress Testing
Graham Buckton and Simon Gaisford
Stress Testing as it Relates to Shipping / Distribution - Real World Measurements and Implications
Stress Testing: Frequently Asked Questions
Steven W. Baertschi, Karen M. Alsante, and Robert A. Reed
"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