Guide on Bioequivalence for Immediate-Release Drugs

FDA is making available a draft guidance entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.” The International Council for Harmonization (ICH) document is the second in the ICH M13 series and describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for additional strengths of orally administered immediate-release solid oral dosage forms (i.e., tablets, capsules, and granules/powders for oral suspension), including considerations for biowaivers. It also provides harmonized criteria and data that support waivers for drug applications with multiple strengths when in vivo BE has been demonstrated for at least one strength using the principles outlined in the final guidance “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” published 10/2024.