Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices /
A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stab...
| Συγγραφή απο Οργανισμό/Αρχή: | |
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| Άλλοι συγγραφείς: | |
| Μορφή: | Ηλεκτρονική πηγή Ηλ. βιβλίο |
| Γλώσσα: | English |
| Έκδοση: |
New York, NY :
Springer New York,
2009.
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| Θέματα: | |
| Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- 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.
