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Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions explains the role of altern… Read more
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Section 1: Bioequivalence Pathways for Oral Drug Products across regulatory bodies with relevant case studies
1. BCS based biowaiver approaches
2. Safe Space based approaches
3. Bioequivalence for drug products acting locally in GI tract
Section 2. Bioequivalence Pathways for Ophthalmic Drug products across regulatory bodies with relevant case studies
4. Ophthalmic Gel Products
5. Ophthalmic Emulsions
6. Ophthalmic Suspensions
Section 3. Bioequivalence Pathways for Topical and Transdermal Drug products across regulatory bodies with relevant case studies
7. Topical Gel Products8. Topical Cream Products
9. Nail Drug Products and possible approaches
10. Pediculicide hair tuft assay-based approaches
11. Transdermal Drug products
12. PBPK Approaches for Topical Drug Products
Section 4. Innovative Bioequivalence pathways for Topical drug products
13. Dermal Microdialysis
14. Dermal Open Flow Microdialysis
15. Tape stripping-based approaches
16. Antimicrobial kill rate studies for dermal products
Section 5. Bioequivalence Pathways for Orally Inhaled and Nasal Drug Products across regulatory bodies with relevant case studies
17. Dry Powder Inhalers for Lung Diseases In vitro considerations for DPI
18. BE Assessment for Inhalational Products
19. Nasal Sprays
20. Computational Fluid Dynamic based approaches for Absorption Prediction for Orally Inhaled and Nasal Products
Section 6. Bioequivalence Pathways for Complex injectables across regulatory bodies with relevant case studies
21. Liposomal Drug products
22. Injectable Microsphere and In Situ Implants
23. Injectable Suspensions
24. Injectable Emulsions
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