- GMP Issues with Emphasis on Dissolution Testing
- Identifying Sources of Error in Sample Testing and Calibration
- Pellicle Formation/Cross-Linking of Gelatin Capsules
- Calibration and Validation of Dissolution Equipment Including Non-Compendial Equipment
- Semi Automation and Full Automation of the Dissolution Lab: Pros and Cons
- Challenges of Developing Discriminating Methods for Poorly Soluble Drugs and Special Dosage Forms
- Method Development, Including Comparators, Suspensions, Special Dosage Forms, Liquid-Filled Capsules
- A Practical Approach to IVIVC
- Overview/Historical Perspective of Dissolution Testing
- Interactions with Formulators, PK, QA, Metrology, Other Sites
- Special Considerations for Each Phase of Development
- QC Test versus Surrogate
- Method Transfer
- Current Regulatory Updates
- Biopharmaceutics Classification System Extensions
- Specification Setting, Including AAPS/FDA Specification Workshop
- USP Initiatives
- Basic Dissolution Testing
- Validation of Dissolution Methods
- Fiber Optics
- Analytical Issues
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