FDA publishes two final guidances for industry: “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” and “Statistical Approaches to Establishing Bioequivalence”

The guidance for industry entitled “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” provides recommendations to applicants planning abbreviated new drug application (ANDA) submissions on how to meet the bioequivalence (BE) requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.

The guidance for industry entitled “Statistical Approaches to Establishing Bioequivalence” provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro BE studies for investigational new drugs (INDs), new drug applications (NDAs), ANDAs, and their amendments and supplements.