Draft Guidance on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA: Narrow Therapeutic Index Drugs

U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (2014). Draft Guidance on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA: Narrow Therapeutic Index Drugs: Narrow Therapeutic Index Drugs.

Type

Report

Intellectual base

Grey literature

Year

2014

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequivalence-studies-pharmacokinetic-endpoints-drugs-submitted-under-abbreviated-new-drug not authoritativefound

Cited from

pharmacology_toxicology

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Primes

• Therapeutic Window
  • The clarity extends to regulatory thinking: narrow-therapeutic-window drugs (NTWDs) are a formal regulatory category, codified by the FDA (2014) in its bioequivalence guidance for narrow-therapeutic-index drugs, requiring special handling (therapeutic drug monitoring, dose adjustment protocols, patient education), whereas wide-window drugs tolerate standard dosing.

    This sourceFDA Office of Generic Drugs. Codifies the regulatory category of narrow-therapeutic-index (NTI) drugs and the heightened bioequivalence and monitoring requirements that follow from a narrow therapeutic window.

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