Bioequivalence Data in ANDA Submissions
Bioequivalence Data in ANDA Submissions How to Demonstrate Bioequivalence in ANDA Submissions Introduction: Why Bioequivalence Matters Bioequivalence (BE) forms the cornerstone of an Abbreviated New Drug Application (ANDA) because it demonstrates that the proposed generic drug performs in the same manner as the reference listed drug (RLD). The U.S. Food and Drug Administration (FDA) mandates…