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.