September 11, 2025
Enroll in M13B Additional Strengths Biowaiver Guideline Webinar
Enroll in the FDA ICH M13B Additional Strengths Biowaiver Guideline Webinar course to access all lessons and resources.
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Presentations, Panel Discussion, and Q&A
About
This webinar provides an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver” that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.
The ICH M13B guideline, the second guideline in the M13 guideline series, provides recommendations for obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. This guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation.