Evidence map›Paper›PMID 34609078›Full record

ReviewPharmacology research & perspectives2021

The use of GA-RxODE (Genetics Algorithms and Running simulations from Ordinary Differential Equations-based model) method to optimize bioequivalence studies.

Ezequiel Omar Nuske, Mikhail Morozov, Héctor Alejandro Serra

Abstract readReview
In one paragraph

Review in Pharmacology research & perspectives, 2021. 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

3 authors.

Ezequiel Omar NuskePharmacology Department, School of Medicine, University of Buenos Aires, Buenos Aires, Argentina.ORCID https://orcid.org/0000-0002-8983-8955
Mikhail MorozovPharmacology Department, School of Medicine, University of Buenos Aires, Buenos Aires, Argentina.
Héctor Alejandro SerraPharmacology Department, School of Medicine, University of Buenos Aires, Buenos Aires, Argentina.ORCID https://orcid.org/0000-0002-4958-0718

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bioequivalence (BE) studies are prerequisite in generic products approval. Normally, they are quite simple in design and expensive in execution, and sometimes suffer ethical questioning. Genetics Algorithms and Running simulations from Ordinary Differential Equations-based model (GA-RxODE) is a multipurpose method used in pharmacokinetic (PK) optimization. It can be used to complete concentration-time (C-T) missing data. In this investigation, GA-RxODE was applied in BE field. For this purpose, three BE studies were selected as a source data comprising formulations of metformin, alprazolam and clonazepam. From them, five blood samples values per volunteer-round from specific preset times were chosen as if BE study was carried out with five instead of the classic 10-20 samples. With the five values of each volunteer a complete C-T curve was simulated by GA-RxODE and certain PK estimation parameters (as maximum concentration, C

Indexed as

AlgorithmsComputer SimulationAlprazolamAnti-Anxiety AgentsClonazepamDrugs, GenericHumansHypoglycemic AgentsMetforminPharmacokineticsTherapeutic EquivalencyAlprazolamAnti-Anxiety AgentsClonazepamDrugs, GenericHypoglycemic AgentsMetforminbioequivalence studiesgeneric drugsgenetics algorithmsNLME modelspharmacokinetic

Identifiers

PMID34609078
PMCPMC8491459

What OpenQuestion holds

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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.