Title:
Pharmaceutical stress testing predicting drug degradation
Author:
Baertschi, Steven W.
ISBN:
9781439801802
Edition:
2nd ed.
Publication Information:
London ; New York : Informa Healthcare, 2010.
Physical Description:
x, 612 p. : ill. (some col.).
Series:
Drugs and the pharmaceutical sciences ; v. 210
Series Title:
Drugs and the pharmaceutical sciences ; v. 210
Contents:
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.
Abstract:
"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.
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