FDA issues draft guidance on bioavailability & bioequivalence studies

The FDA has published draft guidance on Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs. The guidance gives recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. When finalized, this guidance will revise and replace relevant the parts of FDA’s March 2003 guidance.

The guidance covers:

  • Methods to document BA and BE
  • Documenting BA and BE for various dosage forms; and
  • A variety of special topics, including the affect of alcoholic drinks on drug products, and drug products with complex mixtures as the active ingredient.