Back to: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance
🔔 Note: Stop playback at 48:35 to complete this lesson.
Presenter
Nilufer Tampal, PhD
Associate Director of Science Quality
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Nilufer Tampal, from FDA’s Office of Generic Drugs, details the FDA’s extensive efforts to align Product-Specific Guidances (PSGs) with the new M13A bioequivalence recommendations, aiming to significantly reduce the burden on generic drug developers. The core change is a new risk-based approach to bioequivalence testing, where the requirement for both fasting and fed studies is now primarily limited to high-risk products. These high-risk products often involve complex formulations or low solubility, making their performance sensitive to varying gastrointestinal conditions. For non-high-risk products, which are less susceptible to GI variations, a single bioequivalence study (either fasting or fed) is generally sufficient. FDA developed a three-tier risk framework that considers factors like biopharmaceutic properties, drug product characteristics, and food effect to classify products. This systematic revision has led to over 800 PSGs being updated to remove unnecessary studies, streamlining drug development. Applicants are expected to provide clear rationale for their chosen study designs and submit all conducted bioequivalence data, regardless of the outcome, including any studies no longer recommended by the revised PSGs.