Stability Regulations -- Critical Regulatory Requirements for a Stability Program -- Understanding ICH Guidelines Applicable to Stability Testing -- Global Stability Practices -- Post-approval Changes -- Stability Requirements and Regulations -- Understanding and Predicting Pharmaceutical Product Shelf-Life -- Stability Methodologies and Best Practices -- Development of Stability Indicating Methods -- Method Validation and Transfer -- Overview of USP-NF Requirements for Stability Purposes -- Non-chromatographic Methods to Support Stability Program -- Vibrational Spectroscopic Methods for Quantitative Analysis -- Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product -- Evaluation of Stability Data -- Qualification, Calibration, and Maintenance of Stability Chambers -- Stability Operation Practices -- Other Stability Programs -- Combination Products/Drugs in Devices -- Stability Studies for Biologics
Summary
A comprehensive guide to stability testing in pharmaceutical development. It covers various aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. It provides resources for pharmaceutical companies and educational institutions
