Methods for Stability Testing of Pharmaceuticals

Description

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. Front Matter ....Pages i-xiv Regulatory Guidelines on Stability Testing and Trending of Requirements (Dilip Kumar Singh, Saranjit Singh, Sanjay Bajaj)....Pages 1-30 The Stability Dossier: Common Deficiencies and Ways to Improve (Paul Marshall)....Pages 31-51 In Silico Drug Degradation Prediction (Mohammed A. Ali, Rachel Hemingway, Martin A. Ott)....Pages 53-73 Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach (Markus Zimmer)....Pages 75-98 A Model Approach for Developing Stability-Indicating Analytical Methods (Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, Koen Vanhoutte)....Pages 99-121 Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities (Steven Hostyn, Peter Persich, Shalu Jhajra, Koen Vanhoutte)....Pages 123-141 Stability Studies: Facility and Systems (Ashish Gogia, Sumathi V. Rao)....Pages 143-174 User Requirements and Implementation of a Risk-Based, Compliant Stability Management System (Susan Cleary, Parsa Famili, Pedro Jorge)....Pages 175-193 Stability Considerations in the Life Cycle of Generic Products (Sanjay Bajaj, Srinivasan Rajamani, Mona Gogia)....Pages 195-212 Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies (Helen Williams)....Pages 213-232 Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life (B. V. Suresh Kumar, Priyank Kulshrestha, Sandeep Shiromani)....Pages 233-260 Estimation of Stability Based on Monitoring of Shipment and Storage (Manuel Zahn)....Pages 261-292 Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products (Kamla Pathak, Satyanarayan Pattnaik)....Pages 293-305 Stability Testing Issues and Test Parameters for Herbal Medicinal Products (Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur, Rahul Singh Negi)....Pages 307-333 Stability Testing Considerations for Biologicals and Biotechnology Products (Christine P. Chan)....Pages 335-347 Back Matter ....Pages 349-358