Evidence map›Paper›PMID 41402683›Full record

ArticlePharmaceutical research2025

Deep Dive into Generic Drug Applications to Seek Harmonization of Bioequivalence Criteria for Narrow Therapeutic Index Drugs.

Mirette Mina, Zhen Zhang, Wanjie Sun, Krista Anim Anno, Lei Zhang, Wenlei Jiang

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Mirette MinaOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0001-5216-4910
Zhen ZhangOffice of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0009-0003-3383-5506
Wanjie SunOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0002-6919-1939
Krista Anim AnnoOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0001-7249-8344
Lei ZhangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0002-0639-3162
Wenlei JiangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA. Wenlei.Jiang@fda.hhs.gov.ORCID http://orcid.org/0009-0009-3876-638X

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

purposeU.S. Food and Drug Administration (FDA) recommends reference scaled limits and variability comparison for bioequivalence (BE) demonstration of narrow therapeutic (NTI) drugs while most other regulatory agencies apply direct tightening of BE limits. This study evaluates strengths and limitations of different BE criteria using abbreviated new drug application (ANDA) data received by FDA to support harmonization of NTI drug BE criteria.

methodsWe analyzed four-way fully-replicated crossover BE study data in NTI ANDAs, applying BE criteria from different agencies and alternative criteria (e.g., Paixão's criteria, modified Paixão's and FDA criteria) to compare passing rates.

resultsCurrent EMA and FDA criteria seem stringent with NTI drugs having moderate and low within-subject variability (e.g., S

conclusionAlternative FDA criteria with capping at 90.00-111.11% when σ

Indexed as

Drugs, GenericCross-Over StudiesDrug ApprovalHumansTherapeutic EquivalencyUnited StatesUnited States Food and Drug AdministrationDrugs, GenericBioequivalenceICH M13Narrow therapeutic indexVariability comparisonWithin-subject variability

Identifiers

PMID41402683
PMCPMC12975132

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Registered trials

None linked

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.