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GUIDANCE DOCUMENT

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application August 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-D-1464
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance describes how to meet the BE requirements set forth in FDA regulations. The guidance 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. The guidance will be especially useful when planning BE studies intended to be conducted during the postapproval period for certain changes in an ANDA.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1464.

 
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