Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions explains the role of alternative approaches to bioequivalence across various dosage forms, route of administration, and regulatory bodies with an ultimate aim of reducing clinical trial and bioequivalence study burdens. Sections focus on alternative bioequivalence approaches that can be fostered to minimize human testing, along with instigating new ideas and opening new avenues for the development of such approaches. It will be useful to pharmaceutical scientists working to produce affordable medicines to all as well as regulatory agencies, pharmaceutical companies, formulation scientists and clinical scientists.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.
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Elsevier Science Publishing Co Inc
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Broschur/Paperback
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Höhe: 235 mm
Breite: 191 mm
ISBN-13
978-0-12-824141-7 (9780128241417)
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Schweitzer Klassifikation
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. Dr. S. Narasimha Murthy is the CSO of Topical Products Testing LLC, USA. He was former Professor of Pharmaceutics and Drug Delivery at the University of Mississippi School of Pharmacy, USA for over 15 years. Dr. Murthy is a pioneer in nanotechnology-based delivery systems, microneedles and microstructured delivery technologies of drug delivery and diagnosis, dermal and transdermal delivery of drugs and nose to brain delivery of therapeutics. His research programs are funded by NIH, FDA, and Pharmaceutical companies. He has published over 130 research papers and presented over 250 scientific posters in various national and international scientific meetings. He has authored two books and over fifteen book chapters. He is serving on the Editorial Board of several journals including AAPS Pharm Sci Tech, DDIP and J Pharm. Sci. He is a consultant to pharmaceutical and medical device companies in the USA, Israel, Italy, and India. Dr. Murthy has received several awards such as the New Investigator award and Cumberl and Researcher of the year from the University of Mississippi, Global Indus Technovator award from MIT, Endowed Chair for Research at the Ohio Northern University and he was inducted as the Fellow of the American Association of Pharmaceutical Scientists in 2017 and was bestowed with Distinguished Scientist award by American Association of Indian Pharmaceutical Scientists. Dr. Murthy is also a scientific philanthropist. He is the Founder Director of a non-profit research organization, Institute for Drug Delivery and Biomedical Research in Bangalore, India (www.IDBresearch.com).
Herausgeber*in
Principal Scientist and Head 505b2 Division, ALEOR Dermaceuticals, Hyderabad, India
Professor of Pharmaceutics and Drug Delivery, University of Mississippi, USA
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
