This book covers several administration routes and deals with biowaivers for dosage form, routes of administration and geographical jurisdiction. Divided into five sections, including oral drug products, ophthalmic drug products, topical and transdermal drug products, orally inhaled and nasal drug products, and complex injectables, this book includes multiple real-world case studies alongside theory and protocols.
Table of Contents
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 Products 8. 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
Authors
Vaibhav Dubey Principal Scientist and Head 505b2 Division, ALEOR Dermaceuticals, Hyderabad, India. Dr. Dubey is Principal Scientist and Head 505b2 division at ALEOR Dermaceuticals, Hyderabad, INDIA. He also writes on Biowaiver approaches and submissions to various International Regulatory bodies including US FDA, MHRA and EMEA. He has worked in the development of various generic and innovative dosage forms mostly spinning in and around the Topical and Transdermal drug delivery domain. Previously he has served in companies like Sun Pharmaceuticals and Dr. Reddy's Laboratories, in INDIA. He has multiple patents to his credit in the field of nanotechnology and controlled drug delivery systems, alongwith contributing numerous publications in high repute journals, book chapters and poster presentations. Dr. Dubey has been awarded the prestigious Commonwealth fellowship and Federal Commission Scholarship during his PhD along with Indian Drug Manufacturer Association's Award, Prof CS Chouhan Award and University Gold Medals. Narasimha Murthy Professor of Pharmaceutics and Drug Delivery, University of Mississippi, USA. Dr. Murthy is Professor of Pharmaceutics and Drug Delivery in the School of Pharmacy at the University of Mississippi. He has been working on topical delivery with FDA past five years. He is an expert in Q3 characterization of topical products, In vitro release testing and in vitro permeation testing. Dr. Murthy worked extensively on Acyclovir products with FDA team (https://www.fda.gov/media/110262/download). Dr. Murthy continues to work with FDA on various topical products such as gels, foams, creams, lotions and other complex topical products. Dr. Murthy is also an expert in nail delivery and nail formulations. He has developed several nail products and is an expert in evaluating formulations such as nail lacquers, nail gels and other products.Dr. Murthy works on novel technologies such as nanotechnology, microneedles, liposomes and niosomes for dermal, intranasal and nail delivery of drugs. His lab is funded by National Institutes of Health.
