Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices
Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include: Lates...
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| Format: | eBook |
| Language: | English |
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New York, NY
Springer New York
2009, 2009
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| Edition: | 1st ed. 2009 |
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| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 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