Perspectives on Bioequivalence Pathways for Drug Product Approval Across Dosage Form, Route of Administration and Geographical Jurisdictions
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- Englisch ausgewählt
266,99 €
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Beschreibung
Produktdetails
Einband
Taschenbuch
Erscheinungsdatum
01.11.2022
Herausgeber
Vaibhav Dubey + weitereVerlag
ElsevierSeitenzahl
675
Sprache
Englisch
ISBN
978-0-12-824141-7
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.
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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