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

Source: https://www.globalkeysolutions.net/guidances/guidance-document/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new-drug-application/1da84f16-4374-4eb9-87cd-f13d1d965346

> FDA guidance document: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application. Issue date: August 20, 2021. Get complete insights and analysis.

---

## 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: 2021-08-20
- Last Changed: 2021-08-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1464">FDA-2013-D-1464</a>

## Related Documents

- [Data Integrity for In Vivo Bioavailability and Bioequivalence Studies](https://www.globalkeysolutions.net/guidances/guidance-document/data-integrity-for-in-vivo-bioavailability-and-bioequivalence-studies/04d979b3-3f1d-4515-b9c1-f1a8fb7fb19b)
- [Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/updating-anda-labeling-after-the-marketing-application-for-the-reference-listed-drug-has-been-withdrawn-guidance-for-industry/2304b7bc-985b-405c-a33a-6bb322af4fa6)
- [Statistical Approaches to Establishing Bioequivalence](https://www.globalkeysolutions.net/guidances/guidance-document/statistical-approaches-to-establishing-bioequivalence/ecbc1c62-e39f-4980-b654-baa7788c2171)