M13A Bioequivalence Consensus Guideline

FDA has published the International Council for Harmonization (ICH) M13A consensus guideline, Bioequivalence for Immediate-Release Solid Oral Dosage Forms. The document says the guideline is intended to provide recommendations on conducting bioequivalence studies during both the development and post-approval phases for orally administered immediate-release solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

“Deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided,” the ICH says. “Applicants are encouraged to consult the regulatory authority(ies) when an alternate approach is proposed or taken.”

The guideline contains Introduction, General Principles Establishing Bioequivalence, Specific Topics, Documentation, and Glossary.