Generic Drug Product Development

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Focusing on pharmaceutical equivalence and bioequivalence, this volume addresses the scientific and regulatory challenges faced by manufacturers of specialty drug products. It outlines the necessary approaches to demonstrate therapeutic equivalence between generic and brand-name drugs. Additionally, the book covers the assessment of drug product quality and performance, emphasizing the regulatory requirements for various delivery methods, including topical, nasal, inhalation, transdermal, as well as generic biologics and modified release parenteral products.