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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 book's 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.
List of contents
Regulatory Guidelines on Stability Testing and Trending of Requirements.- The Stability Dossier: Common Deficiencies and Ways to Improve.- In Silico Drug Degradation Prediction.- Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach.- A Model Approach for Developing Stability-Indicating Analytical Methods.- Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities.- Stability Studies: Facility and Systems.- User Requirements & Implementation of a Risk-Based, Compliant Stability Management System Based on the FDA New Guidance on DATA Integrity.- Stability Considerations in the Life Cycle of Generic Products.- Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies.- Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life.- Estimation of Stability Based on Monitoring of Shipment and Storage.- Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products.- Stability Testing Issues and Test Parameters for Herbal Medicinal Products.- Stability Testing Considerations for Biologicals and Biotechnology Products.
Summary
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 book’s 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.
