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Generic Drug Product Development: Specialty Dosage Forms

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Generic Drug Product Development: Specialty Dosage Forms - Shargel, Leon, and Kanfer, Isadore
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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 drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of ...

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Generic Drug Product Development: Specialty Dosage Forms 2019, CRC Press, London

ISBN-13: 9780367384395

Paperback

Generic Drug Product Development: Specialty Dosage Forms 2010, CRC Press, Oxford

ISBN-13: 9780849377860

Hardcover