Methods for Stability Testing of Pharmaceuticals /
| Autor Corporativo: | |
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| Otros Autores: | , |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
New York, NY :
Springer New York : Imprint: Humana,
2018.
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| Edición: | 1st ed. 2018. |
| Colección: | Methods in Pharmacology and Toxicology,
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| Materias: |
Tabla de Contenidos:
- 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.