This guidance specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action.
The ICHM13A 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.
On 25 January 2025, the date of coming into effect, ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms will supersede applicable parts of this EMA guideline related to bioequivalence study considerations and data analysis for a non-replicate study design