Drugs

2 Bioequivalence Guidances Published

FDA has published two final guidances related to establishing bioequivalence. The first guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, has recommendations for applicants planning to submit bioequivalence (BE) information in ANDAs and amendments and supplements to ANDAs. The guidance describes how to meet the BE requirements in the Federal Food, Drug, and Cosmetic Act and agency regulations.

It also applies to non-orally administered drug products in which reliance on systemic exposure measures is suitable for establishing BE. “This guidance will also be useful for applicants planning BE studies intended to be conducted during the postapproval period for changes to a drug product approved under an ANDA,” FDA says.

The guidance contains an Introduction, Background, Establishing BE for Different Dosage Forms, Specific Topics, an Appendix, and a Glossary.

The second guidance, Statistical Approaches to Establishing Bioequivalence, has recommendations on how to meet the provisions of part 320 of the agency regulations for all drug products, and replaces a 2/2001 guidance. The document discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

The guidance contains an Introduction, General Considerations, Specific Situations, References, and seven Appendices.

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