Evidence map›Paper›PMID 32034551›Full record

ArticleThe AAPS journal2020

Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits.

Helmut Schütz, Detlew Labes, Michael Tomashevskiy, Mario González-de la Parra, Anastasia Shitova, Anders Fuglsang

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2020. 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. 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

6 authors.

Helmut SchützBEBAC, Neubaugasse 36/11, 1070, Vienna, Austria. helmut.schuetz@bebac.at.ORCID https://orcid.org/0000-0002-1167-7880
Detlew Labes, Lössauer Straße18, 13055, Berlin, Germany.ORCID https://orcid.org/0000-0003-2169-426X
Michael TomashevskiyOnTarget Group, Ul, Pechatnika Grigoryeva, 8, Saint Petersburg, Russian Federation, 191119.
Mario González-de la ParraBiokinetics, S. A. de C. V., Mexico City, Mexico.ORCID https://orcid.org/0000-0003-1349-8955
Anastasia ShitovaQuinta-Analytica Yaroslavl, Leningradsky pr. 52G, Yaroslavl, Russian Federation, 150045.ORCID https://orcid.org/0000-0003-3546-7316
Anders FuglsangFuglsang Pharma, Hiort Lorenzens Vej 6c st.tv., 6100, Haderslev, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In order to help companies qualify and validate the software used to evaluate bioequivalence trials in a replicate design intended for average bioequivalence with expanding limits, this work aims to define datasets with known results. This paper releases 30 reference datasets into the public domain along with proposed consensus results. A proposal is made for results that should be used as validation targets. The datasets were evaluated by seven different software packages according to methods proposed by the European Medicines Agency. For the estimation of CV

Indexed as

Clinical Trials as TopicDatasets as TopicResearch DesignSoftware ValidationTherapeutic EquivalencyData AccuracyHumansReproducibility of Resultsaverage bioequivalence with expanding limitsblack box software validationreference scalingreplicate designs

Identifiers

PMID32034551

What OpenQuestion holds

Textmetadata
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.