Contents

1. Historical Development of Dissolution Testing 2. Compendial Testing Equipment: Qualification, and Sources of Error 3. Compendial Requirements of Dissolution Testing-European Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopoeia 4. The Role of Dissolution Testing in the Regulation of Pharmaceuticals: The FDA Perspective 5. Gastrointestinal Transit and Drug Absorption 6. Physiological Parameters Relevant to Dissolution Testing: Hydrodynamic Considerations 7. Development of Dissolution Tests on the Basis of Gastrointestinal Physiology 8. Orally Administered Drug Products: Dissolution Data Analysis with a View to In Vitro-In Vivo Correlation 9. Interpretation of In Vitro-In Vivo Time Profiles in Terms of Extents, Rates, and Shape 10. Study Design Considerations for IVIVC Studies 11. Dissolution Method Development with a View to Quality Control 12. Dissolution Methods Development: An Industry Perspective 13. Design and Qualification of Automated Dissolution Systems 14. Bioavailability of Ingredients in Dietary Supplements: A Practical Approach to the In Vitro Demonstration of the Availability of Ingredients in Dietary Supplements