Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)

ISBN 10: 0824740211 / ISBN 13: 9780824740214

Editore: CRC Press, 2005

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Riassunto:

The first book devoted to the topic, 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.

Contenuti: Stress Testing: A Predictive Tool. Stress Testing: Relation to the Development Timeline. Stress Testing: Frequently Asked Questions. Stress Testing: Analytical Considerations. Oxidative Susceptibility Testing. Photostability Stress Testing. Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes of Materials from Multiple Sources. The Chemistry of Drug Degradation. The Role of "Mass Balance" in Pharmaceutical Stress Testing. Physical and Chemical Stability Considerations in the Development and Stress Testing of Freeze-Dried Pharmaceuticals. Excipient Compatibility Studies

Dati bibliografici

Titolo: Pharmaceutical Stress Testing: Predicting ...
Casa editrice: CRC Press
Data di pubblicazione: 2005
Legatura: hardcover
Condizione: Good