Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13B Guideline is intended to provide recommendations on 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 to both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. The ICH M13B Guideline is the second Guideline in the foreseen series to describe the scientific and technical aspects of demonstrating BE for additional strengths of a drug product, i.e., obtaining waiver(s) for one or more strengths in an application with multiple strengths when BE has been demonstrated for at least one of the strengths following ICH M13A. How regulatory decisions may be made based on BE assessment is out of the scope of this guideline.

Further information can be found in the M13 Concept Paper and Business Plan.