Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13C Guideline is intended to provide recommendations on data analysis and BE assessment for 1) highly variable drugs, 2) drugs with narrow therapeutic index, and 3) complex BE study design and data analysis considerations, e.g., adaptive BE study design 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 M13C Guideline is the third Guideline in the foreseen series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. 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.
