Generic Drug Product Development: Specialty Dosage Forms

1st Edition

Leon Shargel, Isadore Kanfer

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CRC Press
Published April 19, 2016
Reference - 288 Pages
ISBN 9780429132926 - CAT# KE81969

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Summary

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru

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