FDA published two final guidances for industry: "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" and "Statistical Approaches to Establishing Bioequivalence".
From the announcement:
"The guidance for industry entitled "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequivalence-studies-pharmacokinetic-endpoints-drugs-submitted-under-abbreviated-new-drug?utm_medium=email&utm_source=govdelivery) provides recommendations to applicants planning abbreviated new drug application (ANDA) submissions on how to meet the bioequivalence (BE) requirements….This final guidance is generally 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 establishing BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). This final guidance will also be useful to applicants planning BE studies to be conducted during the post-approval period for changes to a drug product approved under an ANDA.
The guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence" (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-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. This guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches generally and in specific situations."
#fda #BE #Statistics
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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