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Pharmaceutical stress testing : predicting drug degradation

Baertschi, Steven W.

Pharmaceutical stress testing : predicting drug degradation

Baertschi, Steven W.

9781439801802

Second edition.

1 online resource (x, 612 pages)

Drugs and the pharmaceutical sciences ; Volume 210

Drugs and the pharmaceutical sciences ; Volume 210.

1. Introduction / Steven W. Baertschi and Dan W. Reynolds -- 2. Stress testing : a predictive tool / Steven W. Baertschi, Patrick J. Jansen, and Karen M. Alsante -- 3. Stress testing : the chemistry of drug degradation / Steven W. Baertschi, Karen M. Alsante, and Dinos Santafianos -- 4. Stress testing : analytical considerations / Patrick J. Jansen, W. Kimmer Smith, and Steven W. Baertschi -- 5. Stress testing : 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 Fasoni and Angelo Albini -- 8. Practical aspects of conducting photostability stress testing / David Clapham, Allen C. Templeton, Lee J. Klein, and Mark H. Kleinman -- 9. Role of ''mass balance'' in pharmaceutical stress testing / Mark A. Nussbaum, Andreas Kaerner, Patrick J. Jansen, and Steven W. Baertschi -- 10. Solid-state pharmaceutical development : ensuring stability through salt and polymorph screening / Susan M. Reutzel-Edens and Greg A. Stephenson -- 11. Solid-state excipient compatibility testing / Amy S. Antipas, Margaret S. Landis, and W. 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 C. Capaldi -- 16. Stress testing to determine liposome degradation mechanisms / Paul R. Meers and Patrick L. Ahl -- 17. Stress testing of combination therapies / Dan W. Reynolds and Biren K. Joshi -- 18. Rapid stress stability studies for evaluation of manufacturing changes, materials from multiple sources, and stability-indicating methods / Bernard A. Olsen, Michael A. Watkins, and Larry A. Larew -- 19. Stress testing as a predictive tool for the assessment of potential genotoxic degradants / Steven W. Baertschi, David DeAntonis, Alan P. McKeown, Joel Bercu, Stephen Raillard, and Christopher M. Riley -- 20. The power of computational chemistry to leverage stress testing of pharmaceuticals / Donald B. Boyd and Thomas R. Sharp -- 21. Automation in conducting stress testing and excipient compatibility studies / Eric Carlson, Patrick J. Jansen, and Christopher Foti -- 22. Use of isothermal microcalorimetry in stress testing / Graham Buckton and Simon Gaisford -- 23. Temperature excursions during shipment and storage / Manuel Zahn -- 24. Stress testing : frequently asked questions / Steven W. Baertschi, Karen M. Alsante, and Robert A. Reed.

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. Richly illustrated and extensively referenced, this source details the execution and interpretation of small molecule stress testing studies, provides a comprehensive overview of the major aspects of the prediction of drug degradation, presents up-to-date approaches to pharmaceutical stress testing, and much more--Provided by publisher.

Drug stability -- Testing.

Baertschi, Steven W.

Alsante, Karen Mills.

Reed, Robert A.

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