This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the books internationally-based expert contributors fill the chapters with practical guidance. As a volume in the
Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research.?
Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.
1. Regulatory Guidelines on Stability Testing and Trending of Requirements
??????????? Dilip Kumar Singh, Saranjit Singh, and Sanjay Bajaj
2. The Stability Dossier: Common Deficiencies and Ways to Improve
??????????? Paul Marshall
3. In Silico Drug Degradation Prediction
??????????? Mohammed A. Ali, Rachel Hemingway, and Martin A. Ott
4. Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach
??????????? Markus Zimmer
5. A Model Approach for Developing Stability-Indicating Analytical Methods ??????????? Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, and Koen Vanhoutte
6. Protocols for Characterization of Degradation Products with Special Empl#§
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