Evidence map›Paper›PMID 29873094›Full record

ArticleBritish journal of clinical pharmacology2018

Gestational changes in buprenorphine exposure: A physiologically-based pharmacokinetic analysis.

Hongfei Zhang, Hari V Kalluri, Jaime R Bastian, Huijun Chen, Ali Alshabi, Steve N Caritis, Raman Venkataramanan

Open access · bronzeAbstract readEvaluation StudyValidation Study
In one paragraph

Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
6.5field-weighted citation impact, top 4% of its field
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, 36 citations in OpenAlex.

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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

7 authors at 3 institutions in 2 countries.

Hongfei ZhangUniversity of Pittsburgh, Department of Pharmaceutical Sciences, School of Pharmacy, Pittsburgh, PA.ORCID 0000-0003-1087-8186
Hari V KalluriUniversity of Pittsburgh, Department of Pharmaceutical Sciences, School of Pharmacy, Pittsburgh, PA.ORCID 0000-0002-5863-2452
Jaime R BastianIndivior Solutions, Inc.
Huijun ChenTsinghua University, School of Pharmaceutical Sciences, China.
Ali AlshabiUniversity of Pittsburgh, Department of Pharmaceutical Sciences, School of Pharmacy, Pittsburgh, PA.
Steve N CaritisUniversity of Pittsburgh, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, Pittsburgh, PA.
Raman VenkataramananUniversity of Pittsburgh, Department of Pharmaceutical Sciences, School of Pharmacy, Pittsburgh, PA.
University of Pittsburgh · USIndivior (United States) · USTsinghua University · CN

Funding

Pregnancy and Drug Metabolizing Enzymes and TransportersU10HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2004 to 2014
$9.7M
Optimization of Drug Dosing in Pregnant Women through Research and EducationU54HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI VENKATARAMANAN, RAMAN · 2015 to 2019
$3.7M
NICHD NIH HHS U10 HD047905NICHD NIH HHS U54 HD047905
6 · The paper itself

Abstract

aimsBuprenorphine (BUP) is approved by the US Food and Drug Administration for the treatment of opioid addiction. The current dosing regimen of BUP in pregnant women is based on recommendations designed for nonpregnant adults. However, physiological changes during pregnancy may alter BUP exposure and efficacy. The objectives of this study were to develop a physiologically-based pharmacokinetic (PBPK) model for BUP in pregnant women, to predict changes in BUP exposure at different stages of pregnancy, and to demonstrate the utility of PBPK modelling in optimizing BUP pharmacotherapy during pregnancy.

methodsA full PBPK model for BUP was initially built and validated in healthy subjects. A fetoplacental compartment was included as a combined compartment in this model to simulate pregnancy induced anatomical and physiological changes. Further, gestational changes in physiological parameters were incorporated in this model. The PBPK model predictions of BUP exposure in pregnancy and during the postpartum period were compared to published data from a prospective clinical study.

resultsThe predicted BUP plasma concentration-time profiles in the virtual pregnant populations are consistent with the observed data in the 2

conclusionPBPK model-based simulation may be a useful tool to optimize BUP pharmacotherapy during pregnancy, obviating the need to perform pharmacokinetic studies in each trimester and the postpartum period that normally require intensive blood sampling.

Indexed as

Models, BiologicalAdministration, SublingualAdultArea Under CurveBuprenorphineComputer SimulationFemaleHumansMaternal-Fetal ExchangeNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPlacentaPregnancyPregnancy ComplicationsProspective StudiesBuprenorphineNarcotic Antagonistsbuprenorphineopioid dependencePBPKpharmacokineticspregnancy

Identifiers

PMID29873094
PMCPMC6089832
OpenAlexW2806968435

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.