5185859
9780849377860
Exploring the more difficult demonstration of pharmaceutical equivalence and bioequivalence for specialty drug products, this title details various approaches and strategies for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. It discusses the measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products.Shargel, Leon is the author of 'Generic Drug Product Development-specialty Drug Products ', published 2007 under ISBN 9780849377860 and ISBN 0849377862.
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