Generic Drug Product Development

Generic Drug Product Development

Forfatter: Leon Shargel, Isadore Kanfer
Forlag: CRC Press
Udgave: 1
Udgivelsesdato: 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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