Methods for Stability Testing of Pharmaceuticals

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.