| This reference discusses the predictive power and limitations of 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. |
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| Binding: Hardcover |
| Specs: 504 pages | 2 Lbs |
| ISBN: 0824740211 |
| ISBN-13: 9780824740214 |
| New Edition: 1439801797 |
| Edition: 1 |
| Publisher: Taylor & Francis, Incorporated | Publish Date 10/05 | Copyright 2005 |
| Series: Drugs and the Pharmaceutical Sciences |
| Volume: 153 |
Table Of Contents:
1. Introduction
Steven W. Baetschi, Dan W. Reynolds
Stress testing : a predictive tool
Steven W. Baertschi, Patrick J. Jansen
Stress testing : the chemistry of drug degradation
Steven W. Baertschi, Karen M. Alsante
Stress testing : analytical considerations
Patrick J. Jansen, W. Kimmer Smith, Steven W. Baertschi
Stress testing : relation to the development timeline
Steven W. Baertschi, Bernard A. Olsen, Karen M. Alsante
Role of "mass balance" in pharmaceutical stress testing
Mark A. Nussbaum, Patrick J. Jansen, Steven W. Baertschi
Oxidative susceptibility testing
Giovanni Boccardi
Comparative stress stability studies for rapid evaluation of manufacturing changes or materials from multiple sources
Bernard A. Olsen, Larry A. Larew
Physical and chemical stability considerations in the development and stress testing of freeze-dried pharmaceuticals
Steven L. Nail
Photostability stress testing
Elisa Fasani, Angelo Albini
The use of microcalorimetry in stress testing
Graham Buckton, Simon Gaisford
The power of computational chemistry to leverage stress testing of pharmaceuticals
Donald B. Boyd
Solid-state excipient compatibility testing
Amy S. Antipas, Margaret S. Landis
Stress testing : frequently asked questions
Steven W. Baetschi, Karen M. Alsante |
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