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.
