Evidence map›Paper›PMID 28389935›Full record

Trial reportClinical pharmacokinetics2017

Population Pharmacokinetics and Bayesian Estimators for Refined Dose Adjustment of a New Tacrolimus Formulation in Kidney and Liver Transplant Patients.

Jean-Baptiste Woillard, Jean Debord, Caroline Monchaud, Franck Saint-Marcoux, Pierre Marquet

Abstract readClinical Trial, Phase IIMulticenter StudyValidation Study
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
–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

22 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  13. Pharmaceutics · 2023
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  14. Tacrolimus Exposure Before and After a Switch From Twice-Daily Immediate-Release to Once-Daily Prolonged Release Tacrolimus: The ENVARSWITCH Study.Transplant international : official journal of the European Society for Organ Transplantation · 2023
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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

5 authors.

Jean-Baptiste WoillardDepartment of Pharmacology and Toxicology, CHU Limoges, Limoges University Hospital, Limoges Cedex, 87042, France.ORCID 0000-0003-1695-0695
Jean DebordDepartment of Pharmacology and Toxicology, CHU Limoges, Limoges University Hospital, Limoges Cedex, 87042, France.
Caroline MonchaudDepartment of Pharmacology and Toxicology, CHU Limoges, Limoges University Hospital, Limoges Cedex, 87042, France.
Franck Saint-MarcouxDepartment of Pharmacology and Toxicology, CHU Limoges, Limoges University Hospital, Limoges Cedex, 87042, France.
Pierre MarquetDepartment of Pharmacology and Toxicology, CHU Limoges, Limoges University Hospital, Limoges Cedex, 87042, France. pierre.marquet@unilim.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesA new once-daily formulation of tacrolimus (Envarsus MATERIALS AND

methodsFull tacrolimus concentration-time profiles (13 samples) were drawn from 57 liver (113 profiles) and 49 kidney (97 profiles) graft recipients transplanted for at least 6 months and switched from Prograf

resultsThe best limited sampling strategy was 0, 8 and 12 h post-dose, leading to a relative bias ± standard deviation (root-mean-square error) between observed and modelled inter-dose area under the curve in the validation dataset of: 0.32 ± 6.86% (6.87%) for ITSIM and 3.4 ± 13.4% (13.2%) for Pmetrics in kidney transplantation; and 0.89 ± 7.32% (7.38%) for ITSIM and -2.62 ± 8.65% (8.89%) for Pmetrics in liver transplantation.

conclusionPopulation pharmacokinetic models and Bayesian estimators for Envarsus

Indexed as

Models, BiologicalAdultAgedAlgorithmsArea Under CurveBayes TheoremDose-Response Relationship, DrugFemaleHumansImmunosuppressive AgentsKidney TransplantationLiver TransplantationMaleMiddle AgedProspective StudiesTacrolimusImmunosuppressive AgentsTacrolimus

Identifiers

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.