Evidence map›Paper›PMID 37114321›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studies.

Coralie Tardivon, Florence Loingeville, Mark Donnelly, Kairui Feng, Wanjie Sun, Guoying Sun, Stella Grosser, Liang Zhao, Lanyan Fang, France Mentré and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

11 authors.

Coralie TardivonINSERM, IAME, Université de Paris, Paris, France.ORCID 0000-0002-2304-9910
Florence LoingevilleINSERM, IAME, Université de Paris, Paris, France.ORCID 0000-0002-4278-2974
Mark DonnellyDivision of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.ORCID 0000-0001-7537-9615
Kairui FengDivision of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Wanjie SunOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Guoying SunOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Stella GrosserOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Liang ZhaoDivision of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.ORCID 0000-0002-0257-9082
Lanyan FangDivision of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
France MentréINSERM, IAME, Université de Paris, Paris, France.ORCID 0000-0002-7045-1275
Julie BertrandINSERM, IAME, Université de Paris, Paris, France.ORCID 0000-0002-6568-1041

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a traditional pharmacokinetic (PK) bioequivalence (BE) study, a two-way crossover study is conducted, PK parameters (namely the area under the time-concentration curve [AUC] and the maximal concentration [

Indexed as

Therapeutic EquivalencyArea Under CurveCross-Over StudiesHumans

Identifiers

PMID37114321
PMCPMC10349197

What OpenQuestion holds

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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.