# Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new-drug-application/0cf09c0e-b1b7-4d10-96f0-c30985d6ee93

> FDA guidance document: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application. Issue date: May 29, 2026. Get complete insights and analysis.

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## Details

- Title: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-05-29
- Last Changed: 2026-05-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1464">FDA-2013-D-1464</a>

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