Evidence map›Paper›PMID 33835478›Full record

ArticleClinical pharmacology and therapeutics2021

Do Inhibitory Metabolites Impact DDI Risk Assessment? Analysis of in vitro and in vivo Data from NDA Reviews Between 2013 and 2018.

Claire Steinbronn, Xinning Yang, Jingjing Yu, Hristina Dimova, Shiew-Mei Huang, Isabelle Ragueneau-Majlessi, Nina Isoherranen

Open access · greenAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 19% of its field
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

6 citing papers in PubMed, 16 citations in OpenAlex.

  1. Role of metabolites in drug-drug interactions.Drug metabolism and pharmacokinetics · 2026
    Review
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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

7 authors at 4 institutions in 1 country.

Claire SteinbronnDepartment of Pharmaceutics, University of Washington, Seattle, Washington, USA.
Xinning YangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jingjing YuDepartment of Pharmaceutics, University of Washington, Seattle, Washington, USA.
Hristina DimovaCenter for Tobacco Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
Shiew-Mei HuangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Isabelle Ragueneau-MajlessiDepartment of Pharmaceutics, University of Washington, Seattle, Washington, USA.
Nina IsoherranenDepartment of Pharmaceutics, University of Washington, Seattle, Washington, USA.
University of Washington · USCenter for Drug Evaluation and Research · USInterAction · USUnited States Food and Drug Administration · US

Funding

Pharmacological Sciences SupplementT32GM007750 · NIGMS · UNIVERSITY OF WASHINGTON · PI ATKINS, WILLIAM M · 1985 to 2023
$12.6M
NIGMS NIH HHS T32 GM007750
6 · The paper itself

Abstract

Evaluating the potential of new drugs and their metabolites to cause drug-drug interactions (DDIs) is critical for understanding drug safety and efficacy. Although multiple analyses of proprietary metabolite testing data have been published, no systematic analyses of metabolite data collected according to current testing criteria have been conducted. To address this knowledge gap, 120 new molecular entities approved between 2013 and 2018 were reviewed. Comprehensive data on metabolite-to-parent area under the curve ratios (AUC

Indexed as

Drug InteractionsArea Under CurveBiotransformationCytochrome P-450 Enzyme InhibitorsDatabases, FactualHumansLiverPharmaceutical PreparationsPharmacokineticsRisk AssessmentCytochrome P-450 Enzyme InhibitorsPharmaceutical Preparations

Identifiers

PMID33835478
PMCPMC9794360
OpenAlexW3142333332

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.