Regulatory guidelines on bioequivalence (BE) provide the scientific and technical framework for demonstrating that a Test product and Reference product have comparable bioavailability and are expected to provide equivalent therapeutic performance. These guidelines describe how BE studies should be designed, conducted, analyzed, and reported.
A list of key bioequivalence guidelines published by major
regulatory authorities is provided below:
ICH Guidelines on Bioequivalence Study
· ICH M13 – Bioequivalence for Immediate-Release Solid Oral Dosage Forms
· ICH M10 – Bioanalytical Method Validation and Study Sample Analysis
FDA Guidelines on Bioequivalence Study
· Product-Specific Guidances (PSGs) for Generic Drug Development
· Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
· Statistical Approaches to Establishing Bioequivalence
· Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs
· Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
· Food-Effect Bioavailability and Fed Bioequivalence Studies
EMA Guidelines on Bioequivalence Study
· Guideline on the Investigation of Bioequivalence
WHO Guidelines on Bioequivalence Study
· Guidance for organizations performing in vivo bioequivalence studies
For immediate-release oral solid dosage forms, ICH M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms is now the principal harmonized guideline. It addresses key aspects such as study design, selection of subjects, fasting or fed conditions, reference-product selection, blood-sampling schedules, PK parameters, statistical evaluation, and interpretation of BE results.
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