Generic Drug Product Development

Generic Drug Product Development

Author: Leon Shargel, Isadore Kanfer
Publisher: CRC Press
Edition: 1
Published date: 2016
ISBN: 9780849377860

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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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