Handbook of Stability Testing in Pharmaceutical Development : Regulations, Methodologies, and Best Practices /
| Autor Corporativo: | |
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| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
New York, NY :
Springer New York : Imprint: Springer,
2009.
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| Edición: | 1st ed. 2009. |
| Materias: |
Tabla de Contenidos:
- 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.