Methods for Stability Testing of Pharmaceuticals
Humana Press Inc. (Verlag)
978-1-4939-9258-4 (ISBN)
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.
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.
Erscheinungsdatum | 08.06.2019 |
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Reihe/Serie | Methods in Pharmacology and Toxicology |
Zusatzinfo | 42 Illustrations, color; 51 Illustrations, black and white; XIV, 358 p. 93 illus., 42 illus. in color. |
Verlagsort | Totowa, NJ |
Sprache | englisch |
Maße | 178 x 254 mm |
Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
Medizin / Pharmazie ► Pharmazie | |
Schlagworte | Active pharmaceutical ingredient (API) • Drug Delivery Systems • drug development • Drug expiration • pharmaceutical Products • regulatory guidelines • Stability programs • Test parameters |
ISBN-10 | 1-4939-9258-9 / 1493992589 |
ISBN-13 | 978-1-4939-9258-4 / 9781493992584 |
Zustand | Neuware |
Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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