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Generic Drug Product Development
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Generic Drug Product Development : Specialty Dosage Forms

Book Details

Format Hardback or Cased Book
ISBN-10 0849377862
ISBN-13 9780849377860
Publisher Taylor & Francis Inc
Imprint CRC Press Inc
Country of Manufacture GB
Country of Publication GB
Publication Date Mar 25th, 2010
Print length 288 Pages
Weight 530 grams
Dimensions 23.70 x 16.10 x 2.10 cms
Ksh 34,200.00
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Generic Drug Product Development

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 topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.



The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.


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