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Generic Drugs

Generic Drug Product Development: Specialty

Drug Products

Publication Date   June 2007
Publisher   Informa Healthcare
Product Type   Book
Pages   400
ISBN Number   978-0-8493-7786-0
Product Code   IFH095
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Price £115.00

approximately: $215 | €146

Summary


Exploring the more difficult demonstration of pharmaceutical equivalence and bioequivalence for specialty drug products, this title details various approaches and strategies for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. It discusses the measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products

Content


  • Introduction
  • Non-Systemically Absorbed Oral Drug Products
  • Topical Drugs.Nasal and Inhalation Drug Products
  • Transdermal Drug Delivery
  • Modified Release Parenteral Drug Products
  • Generic Biologics