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Generic Drug Product Development: International Regulatory Requirements for Bioequivalence

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Generic Drug Product Development: International Regulatory Requirements for Bioequivalence

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

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This publication is available in both printed and electronic format:

    

Book Specifications

  • Available to Purchase
  • Published: February 2010
  • ISBN: 9780849377853
  • eISBN: 9781420020021
  • First Edition
  • 332 pages
  • Format: Hardcover
  • Size: 6" x 9"
  • 50 Black and White Illustrations

Quick Overview

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

$270.00
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Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative.

However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country.  This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.