FDA Offers Guidance on How to Include Bioequivalence Info in ANDAs

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FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

FDA announced the availability of a draft guidance, “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA,” on August 20, 2021, which provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. Specifically, the guidance:

  • Describes how to meet the BE requirements set forth in FDA regulations
  • Is applicable to dosage forms intended for oral administration and to non-orally administered drug products in which reliance on systemic exposure measures is suitable for documenting BE
  • Will be useful when planning BE studies conducted during the post-approval period for certain changes in an ANDA

In general, applicants for ANDAs must use an approach that is the most accurate, sensitive, and reproducible, according to the draft guidance. The draft guidance also says that in-vivo and/or in-vitro methods can be used to establish BE. Specifically, the draft guidance covers:

  1. Establishing BE (including pharmacokinetic studies)
  2. Establishing BE for different dosage forms (including oral solutions, immediate-release products, such as capsules and tablets, suspensions, modified-release products, chewable tablets, orally-disintegrating tablets, sublingual, and transdermal)
  3. Moieties to be measured
  4. Long half-life drugs
  5. Alcoholic beverage effects on modified-release drug products
  6. Endogenous compounds
  7. In-vitro dissolution testing
  8. Enteral feeding tube

Source: FDA