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Generic Drug Product Development: Specialty Dosage Forms

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Generic Drug Product Development: Specialty Dosage Forms

By Leon Shargel, Applied Biopharmaceutics, Raleigh, North Carolina, USA
Isadore Kanfer, Rhodes University, Grahamstown, South Africa

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This publication is available in both printed and electronic format:

    

Book Specifications

  • Available to Purchase
  • Published: February 2010
  • ISBN: 9780849377860
  • eISBN: 9781420020038
  • First Edition Edition
  • 288 pages
  • Format: Hardcover
  • Size: 6" x 9"
  • 50 Black and White Illustrations

Quick Overview

Details various approaches and strategies for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.
$250.00
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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.