ArticleThe AAPS journal2025
Analysis on the Impact of U.S. FDA's Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications.
Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing.Pharmaceutics · 2026Review
- Importance of Single Global Regulatory Standards for the Assessment of Generic and Biosimilar Medicines to Advance Patient Access.The AAPS journal · 2026Article
- Deep Dive into Generic Drug Applications to Seek Harmonization of Bioequivalence Criteria for Narrow Therapeutic Index Drugs.Pharmaceutical research · 2025Article
- A Proposal for Alternative FDA Bioequivalence Criteria for Narrow Therapeutic Index Drug Products to Support Future Harmonization.Pharmaceutical research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since 2012, the U.S. Food and Drug Administration (FDA) has developed classification criteria of narrow therapeutic index (NTI) drug products and tightened bioequivalence (BE) standards for these products by recommending a fully replicated, two-sequence, two-treatment, four-period crossover study design where BE is based on passing both scaled average BE criterion and within-subject variability comparison criterion, as well as the average BE criterion of 80.00%-125.00%. Currently, the BE study design and criteria for NTI drugs are somewhat different across regulatory agencies. The objective of this study is to survey pharmacokinetic BE data of abbreviated new drug applications (ANDAs) of NTI drugs submitted to the FDA with initial submission dates between January 1, 2013 and October 1, 2022 to identify the impact of FDA's current BE approach on generic NTI approval. Thirty-three NTI drug products from 100 ANDAs were identified with 93 ANDAs included in analysis. Eighty-seven ANDAs had four-way crossover studies, with 69 and 106 fed and fasting BE studies, respectively. For all NTI drugs, the range of average S
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Identifiers
39939514What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.