Pharmaceutical Stress Testing. Predicting Drug Degradation

Description

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 traditional drug substances. This is the only guide available to tackle this subject in-depth. The 2nd 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).

Contents

1. Introduction - Steven W. Baertschi and Dan W. Reynolds
2. Stress Testing: A Predictive Tool - Steven W. Baertschi, Patrick J. Jansen, K.M. Alsante, Dan Reynolds and Biren Joshi
3. The Chemistry of Drug Degradation - Steven W. Baertschi, Karen M. Alsante and Dinos Santifianos
4. Stress Testing: Analytical Considerations - Patrick J. Jansen, W. Kimmer Smith, and Steven W. Baertschi
5. Relation to the Development Timeline - Steven W. Baertschi, Bernard A. Olsen, Karen M. Alsante and Robert A. Reed.
6. Oxidative Susceptibility Testing - Paul Harmon and Giovanni Boccardi
7. Photostability Stress Testing - Elisa Fasani and Angelo Albini
8. Practical Aspects of Conducting Photostability Stress Testing - David Clapham, Allen Templeton, Lee J. Klein, and Mark H. Kleinman
9. Role of ‘‘Mass Balance’’ in Pharmaceutical Stress Testing - Mark A. Nussbaum, Patrick J. Jansen, Steven W. Baertschi, Andreas Kaerner and Bernard A. Olsen.
10. Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening - Gregory A. Stephenson and Susan Reutzel-Edens
11. Solid-State Excipient Compatibility Testing - Amy S. Antipas, Margaret S. Landis and Peter Wuelfing
12. Small Molecule Parenteral Drugs: Practical Aspects of Stress Testing - Andreas Abend, Brett Duersch and Kyle Fiszlar
13. Stability Considerations in Development of Freeze Dried Pharmaceuticals - Steven L. Nail
14. Stress Testing of Therapeutic Monoclonal Antibodies - Michael R. DeFelippis, Bryan J. Harmon, Lihua Huang and Muppalla Sukumar
15. Stress Testing of Oligonucleotides - Daniel Capaldi
16. Stress Testing to Determine Liposome Degradation Mechanisms - Patrick Ahl and Paul Meers
17. Stress Testing of Combination Therapies - Dan Reynolds and Biren Joshi
18. 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
19. 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
20. The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals - Thomas R. Sharp and Donald B. Boyd
21. Use of Automation in Conducting Stress Testing and Excipient Compatibility Studies - Chris Foti, Patrick Jansen, Eric Carlson
22. The Use of Microcalorimetry in Stress Testing - Graham Buckton and Simon Gaisford
23. Stress Testing as it Relates to Shipping / Distribution – Real World Measurements and Implications - Manuel Zahn
24. Stress Testing: Frequently Asked Questions - Steven W. Baertschi, Karen M. Alsante and Robert A. Reed

Author Bio

Steve W. Baertschi is a Research Fellow, Eli Lilly and Company. Dr Baertschi’s research interests include impurity isolation/purification and structure elucidation, mechanisms of drug degradation reactive intermediates and drug-excipient interactions. Dr Baertschi has organized or chaired several scientific symposia on forced drug degration, photostability and impurity investigations and has published widely on the topics. Dr Baertschi received his degree in chemistry from David Lipscomb University, Nashvile, Tennessee and received his PhD in organic chemistry from Vanderbilt University, Nashville, Tennessee.

Karen M. Alsante is a Research Fellow, Pfizer PharmaTherapeutics Pharmaceutical Sciences in Groton, CT. Dr Alsante’s experience has included leading drug degradation/impurity isolation, solid state characterization as well as early analytical research activities starting in partnership with Discovery and progressing through development to Phase 2 clinical trials. Dr. Alsante organized and chaired several scientific conferences on forced drug degration, photostability and oxidation and has published extensively on these topics. Dr. Alsante received a BA with honors in chemistry from Holy Cross College in 1989 and her PhD in organic chemistry from Duke University in 1994.

Robert R. Reed, is Vice President, CMC and Technological Operations for Celsion Corporation overseeing the CMC, QA and Technical Operations functions. Dr Reed most recently was Vice President, Pharmaceutical Operations at XenoPort, Inc., and has over 20 years of experience across Celsion Corp., XenoPort, Inc, Merck & Company, Inc., and The Liposome Company, Inc., with extensive scientific and regulatory experience in the design and development of pharmaceutical products. Dr Reed holds a Ph.D. in Analytical Chemistry from The University of North Carolina at Chapel Hill and was the recipient of a 3 year NIH Postdoctoral Individual Award at Princeton University.