ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during 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 M13A Guideline is the first guideline in a foreseen ICH series describing the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. For more information on harmonisation of BE, please refer to the dedicated ICH M13 page.
On 25 January 2025, the date of coming into effect, ICH M13A will supersede applicable parts of the EMA Guideline on the investigation of bioequivalence related to bioequivalence study considerations and data analysis for a non-replicate study design (see Tier 1 in the ICH M13 Concept_Paper – ich.org)…
