Zdrowie i gospodarka · 25/01/2012

FDA Releases Draft and Revised Draft Bioequivalence Recommendations for Industry

The Food and Drug Administration (FDA) has made additional draft and revised draft product-specific bioequivalence (BE) recommendations available, providing guidance on designing BE studies to support abbreviated new drug applications (ANDAs). These recommendations were developed using the process outlined in the FDA's 2007 guidance on bioequivalence recommendations for specific products.