Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions - Vaibhav Dubey; Narasimha Murthy; | Foyles Bookstore
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Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions
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Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions (Paperback)

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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 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.

BusinessIndustry & industrial studiesManufacturing industriesPharmaceutical industriesMedical & VeterinaryBrances of medicinePharmacologyMedical & VeterinaryMedicine: general issuesMedical equipment & techniquesMedical research Publisher: Elsevier Science Publishing Co Inc Publication Date: 01/11/2022 ISBN-13: 9780128241417  Details: Type: Paperback Format: Books
Availability: Pre-order for despatch on publication. Pre-Order

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. 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 ( 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.

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