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Scientific Foundations For Regulating Drug Product Quality

With contributions by many influential scientists, this publication offers cutting-edge information from the Scientific Foundations and Applications for the Biopharmaceutics Classification System (BCS) and In Vitro/In Vivo Correlations Workshop held April 14-16, 1997 in Arlington, VA.


Key Features

  • Regulatory status and scientific foundation of three drug product quality regulatory guidelines;
  • General outline of a biopharmaceutics classification guidance that will be used as a basis for approving waivers for in vivo bioequivalence trials; and
  • Comprehensive coverage and discussion of current regulatory guidances in the area of immediate release and modified release dosage forms.


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Contact: Denise Dixon
dixon@aaps.org
703-518-8418
American Association of Pharmaceutical Scientists
15-Jan-1998


Page: 1

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