ICH M13A - Bioequivalence for Immediate-Release Solid Oral Dosage Forms

What it says

This guideline harmonizes the design and conduct of bioequivalence studies for immediate-release solid oral dosage forms with systemic action, addressing matters such as study design, the reference product, the study population and the evaluation of results, to support generic and other applications relying on bioequivalence.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It aims to reduce differences in what regulators in different regions expect, so one study can support several submissions.
• The bioanalytical method used in the study needs to be validated, which links it to ICH M10.
• Companion guidance is being developed to cover additional aspects of bioequivalence.

What inspectors look for

• Whether the study followed the approved protocol and the design principles expected.
• Whether the bioanalytical data are reliable and fully traceable.
• Whether the test product is representative of the product to be marketed.

Related regulations