Pharmaceutical Stress Testing

Predicting Drug Degradation

Steven W. Baertschi, Karen M. Alsante, Robert A. Reed (Herausgeber)

Buch | Hardcover

504 Seiten

2005
Crc Press Inc (Verlag)
978-0-8247-4021-4 (ISBN)

Infos

Pharmaceutical Stress Testing

---

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.

Inhalt

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

Produkt-Details

• Erscheint lt. Verlag: 24.6.2005
• Reihe/Serie: Drugs and the Pharmaceutical Sciences
• Zusatzinfo: 48 Tables, black and white; 306 Illustrations, black and white
• Verlagsort: Bosa Roca
• Sprache: englisch
• Maße: 152 x 229 mm
• Gewicht: 798 g
• Themenwelt: Technik
• ISBN-10: 0-8247-4021-1 / 0824740211
• ISBN-13: 978-0-8247-4021-4 / 9780824740214
• Zustand: Neuware