Bioequivalence for Immediate-Release Solid Oral Dosage Forms

The recent FDA 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, like tablets, capsules, and granules/powders for oral suspension.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. Applicants are encouraged to check the regulatory authority or authorities when an alternate approach is taken.

Source: FDA