Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Regulatory documents
3. Relevant literature
4. The process of absorption in the GI tract
5. Schematic of the process of absorption in the GI tract
6. Dissolution testing requirements
7. Discriminative method
8. Study the substance’s properties
9. The Biopharmaceutics Classification System (BCS)
10. Biopharmaceutical solubility (1)
11. Equipment
12. Biopharmaceutical solubility: High solubility
13. Biopharmaceutical solubility: Indapamide
14. Biopharmaceutical solubility: Literature data (1)
15. Biopharmaceutical solubility: Literature data (2)
16. Biopharmaceutical solubility (2)
17. Sink conditions
18. FDA dissolution database
19. FDA dissolution database: Dissolution methods
20. Who takes part in the methodology development process?
21. Choosing equipment
22. Potential issues with the paddle apparatus
23. Cone formation
24. Examples of sinkers
25. Choosing equipment: Rotating basket
26. BCS 1st class (1)
27. BCS 1st class (2)
28. BCS 2nd class
29. BCS 2nd class: pH-independent substances
30. BCS 2nd class: Dissolution medium of pH higher than 7.5
31. BCS 2nd class: Undesirable choice
32. BCS 2nd class: The best choice
33. BCS 3rd and 4th classes
34. Sources of variability
35. Degassing
36. Summary
37. Acknowledgements and disclosures

Topics Covered

• Absorption in the GI
• Dissolution testing requirements
• Discriminative method
• The Biopharmaceutics Classification System (BCS)
• Biopharmaceutical solubility
• Sink condition
• FDA dissolution database

Links

Categories:

• Metabolism & Nutrition
• Pharmaceutical Sciences

External Links

• Slide 14: Biopharmaceutics classification system and biowaiver focus group
• Slide 18: FDA Dissolution database

Talk Citation

Publication History

• Published on December 31, 2025

Financial Disclosures

• CEO of the Center of Pharmaceutical Analytics (CPHA).