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Generic Drug Product Development: Specialty Dosage Forms
Hardcover
ISBN13: 9780849377860
Publisher: Crc Pr Inc
Published: Mar 25 2010
Pages: 288
Weight: 1.15
Height: 0.90 Width: 6.10 Depth: 9.10
Language: English
This volume 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 book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.
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