Evidence map›Paper›PMID 28050196›Full record

ArticleComputational and mathematical methods in medicine2016

A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers.

Suyan Tian, Howard H Chang, Dana Orange, Jingkai Gu, Mayte Suárez-Fariñas

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Computational and mathematical methods in medicine, 2016. 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

5 authors.

Suyan TianDivision of Clinical Research, First Hospital of Jilin University, 71 Xinmin Street, Changchun, Jilin 130021, China; Center for Clinical and Translational Science, The Rockefeller University, 1230 York Avenue, New York, NY 10065, USA; School of Mathematics, Jilin University, 2699 Qianjin Street, Changchun, Jilin 130012, China.ORCID 0000-0002-5942-1542
Howard H ChangDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
Dana OrangeLaboratory of Molecular Neurooncology, The Rockefeller University, 1230 York Avenue, New York, NY 10065, USA; Division of Rheumatology, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021, USA.
Jingkai GuClinical Pharmacology Center, Research Institute of Translational Medicine, First Hospital of Jilin University, Dongminzhu Street, Changchun 130021, China; College of Life Science, Jilin University, 2699 Qianjin Street, Changchun 130012, China.ORCID 0000-0002-4731-6649
Mayte Suárez-FariñasCenter for Clinical and Translational Science, The Rockefeller University, 1230 York Avenue, New York, NY 10065, USA; Center for Biostatistics, Department of Population, Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Department of Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.ORCID 0000-0001-8712-3553

Funding

TRANSFORMING TRANSLATIONAL SCIENCE AND EDUCATION TO BENEFIT HUMAN HEALTHUL1RR024143 · NCRR · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2006 to 2011
$49.1M
NCRR NIH HHS UL1 RR024143
6 · The paper itself

Abstract

In order to test if two chemically or pharmaceutically equivalent products have the same efficacy and/or toxicity, a bioequivalence (BE) study is conducted. The 80%/125% rule is the most commonly used criteria for BE and states that BE cannot be claimed unless the 90% CIs for the ratio of selected pharmacokinetics (PK) parameters of the tested to the reference drug are within 0.8 to 1.25. Considering that estimates of these PK parameters are derived from the concentration-versus-time curves, a direct comparison between these curves motivates an alternative and more flexible approach to test BE. Here, we propose to frame the BE test in terms of an equivalence of concentration-versus-time curves which are constructed using local polynomial smoother (LPS). A metric is presented to quantify the distance between the curves and its 90% CIs are calculated via bootstrapping. Then, we applied the proposed procedures to data from an animal study and found that BE between a generic drug and its brand name cannot be concluded, which was consistent with the results by applying the 80%/125% rule. However, the proposed procedure has the advantage of testing only on a single metric, instead of all PK parameters.

Indexed as

Pharmaceutical PreparationsTherapeutic EquivalencyAlgorithmsAnimalsArea Under CurveComputer SimulationDogsDose-Response Relationship, DrugDrugs, GenericFemaleMaleModels, StatisticalReference ValuesDrugs, GenericPharmaceutical Preparations

Identifiers

PMID28050196
PMCPMC5165228

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Registered trials

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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.