Evidence map›Paper›PMID 38769016›Full record

ArticleDrug metabolism and disposition: the biological fate of chemicals2024

Development and Verification of a Full Physiologically Based Pharmacokinetic Model for Sublingual Buprenorphine in Healthy Adult Volunteers that Accounts for Nonlinear Bioavailability.

Matthijs W van Hoogdalem, Ryota Tanaka, Trevor N Johnson, Alexander A Vinks, Tomoyuki Mizuno

Abstract read
In one paragraph

Article in Drug metabolism and disposition: the biological fate of chemicals, 2024. 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

5 authors.

Matthijs W van HoogdalemDivision of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (M.W.v.H., R.T., A.A.V., T.M.); James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (M.W.v.H.); Certara UK Limited, Sheffield, United Kingdom (T.N.J.); and Department of Pediatrics (A.A.V., T.M.) and Center for Addiction Research (A.A.V., T.M.), College of Medicine, University of Cincinnati, Cincinnati, Ohio.
Ryota TanakaDivision of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (M.W.v.H., R.T., A.A.V., T.M.); James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (M.W.v.H.); Certara UK Limited, Sheffield, United Kingdom (T.N.J.); and Department of Pediatrics (A.A.V., T.M.) and Center for Addiction Research (A.A.V., T.M.), College of Medicine, University of Cincinnati, Cincinnati, Ohio.ORCID 0000-0002-8452-7971
Trevor N JohnsonDivision of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (M.W.v.H., R.T., A.A.V., T.M.); James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (M.W.v.H.); Certara UK Limited, Sheffield, United Kingdom (T.N.J.); and Department of Pediatrics (A.A.V., T.M.) and Center for Addiction Research (A.A.V., T.M.), College of Medicine, University of Cincinnati, Cincinnati, Ohio.ORCID 0000-0003-0778-0081
Alexander A VinksDivision of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (M.W.v.H., R.T., A.A.V., T.M.); James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (M.W.v.H.); Certara UK Limited, Sheffield, United Kingdom (T.N.J.); and Department of Pediatrics (A.A.V., T.M.) and Center for Addiction Research (A.A.V., T.M.), College of Medicine, University of Cincinnati, Cincinnati, Ohio.ORCID 0000-0003-4224-2967
Tomoyuki MizunoDivision of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (M.W.v.H., R.T., A.A.V., T.M.); James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (M.W.v.H.); Certara UK Limited, Sheffield, United Kingdom (T.N.J.); and Department of Pediatrics (A.A.V., T.M.) and Center for Addiction Research (A.A.V., T.M.), College of Medicine, University of Cincinnati, Cincinnati, Ohio tomoyuki.mizuno@cchmc.org.ORCID 0000-0002-8471-9826

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI MEINZEN-DERR, JAREEN, STRAWN, JEFFREY ROBERT · 2015 to 2024
$37.5M
The Indiana University-Ohio State University Maternal and Pediatric Precision in Therapeutics Data, Model, Knowledge, and Research Coordination Center (IU-OSU MPRINT DMKRCC)P30HD106451 · NICHD · INDIANA UNIVERSITY INDIANAPOLIS · PI Lang Li, Sara K Quinney · 2021 to 2026
$24.1M
NCATS NIH HHS UL1 TR001425NICHD NIH HHS P30 HD106451
6 · The paper itself

Abstract

Sublingual buprenorphine is used for opioid use disorder and neonatal opioid withdrawal syndrome. The study aimed to develop a full physiologically based pharmacokinetic (PBPK) model that can adequately describe dose- and formulation-dependent bioavailability of buprenorphine. Simcyp (v21.0) was used for model construction. Four linear regression models (i.e., untransformed or log transformed for dose or proportion sublingually absorbed) were explored to describe sublingual absorption of buprenorphine across dose. Published clinical trial data not used in model development were used for verification. The PBPK model's predictive performance was deemed adequate if the geometric means of ratios between predicted and observed (P/O) area under the curve (AUC), peak concentration (C

Indexed as

Analgesics, OpioidBiological AvailabilityBuprenorphineHealthy VolunteersModels, BiologicalAdministration, SublingualAdultArea Under CurveDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedNonlinear DynamicsYoung AdultAnalgesics, OpioidBuprenorphine

Identifiers

PMID38769016
PMCPMC11257693

What Socratic 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 Socratic graph.