3rd Edition
Drug Stability, Revised, and Expanded Principles and Practices
792 Pages
by
CRC Press
Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning,... Read more
Preface 1. Introductory Overview 2. Solution Kinetics 3. Kinetic pH Profiles 4. Oxidation in Solution 5. Catalysis, Complexation, and Photolysis 6. Solid State Stability 7. Interactions of Moisture with Solids 8. Physical Characteristics of Solids 9. Preformulation 10. Physical Testing 11. Development and Validation of HPLC Stability-Indicating Assays 12. Stability Testing of Clinical Trial Materials 13. A Rational Approach to Stability Testing and Analytical Development for NCE, Drug Substance, and Drug Products: Marketed Product Stability Testing 14. Packaging, Package Evaluation, Stability, and Shelf-Life 15. Industrial Stability Testing in the United States and Computerization of Stabililty Data 16. Stability of Polypeptides and Proteins17. Regulatory Aspects of Stability Testing in Europe 18. Regulatory and Scientific Aspects of Stability Testing: Present and Possible Future Trends
Biography
Jens T. Carstensen, Madison, Wisconsin. C. T. Rhodes, University of Rhode Island Kingston, Rhode Island.
