Evidence map›Paper›PMID 30059145›Full record

ArticleClinical pharmacology and therapeutics2018

Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches.

Yingying Guo, Xiaoyan Chu, Neil J Parrott, Kim L R Brouwer, Vicky Hsu, Swati Nagar, Pär Matsson, Pradeep Sharma, Jan Snoeys, Yuichi Sugiyama and 5 more

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing 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

58 citing papers in PubMed.

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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

15 authors.

Yingying GuoInvestigational Drug Disposition, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana,, USA.
Xiaoyan ChuDepartment of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, Merck & Co., Inc., Kenilworth, New Jersey,, USA.
Neil J ParrottPharmaceutical Sciences, Pharmaceutical Research and Early Development, Roche Innovation Centre Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Kim L R BrouwerDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,, USA.
Vicky HsuOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland,, USA.
Swati NagarDepartment of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, Pennsylvania,, USA.
Pär MatssonDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.
Pradeep SharmaSafety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca R&D, Cambridge, UK.
Jan SnoeysDepartment of Pharmacokinetics, Dynamics, and Metabolism, Janssen R&D, Beerse, Belgium.
Yuichi SugiyamaSugiyama Laboratory, RIKEN Innovation Center, RIKEN Research Cluster for Innovation, Yokohama, Japan.
Daniel TatosianDepartment of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, Merck & Co., Inc., Kenilworth, New Jersey,, USA.
Jashvant D UnadkatDepartment of Pharmaceutics, University of Washington, Seattle, Washington,, USA.
Shiew-Mei HuangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland,, USA.
Aleksandra GaletinCentre for Applied Pharmacokinetic Research, School of Health Sciences, The University of Manchester, Manchester, UK.
International Transporter Consortium

Funding

Understanding Fetal Exposure to Cannabinoids Through In Vitro and In Vivo StudiesP01DA032507 · NIDA · UNIVERSITY OF WASHINGTON · PI UNADKAT, JASHVANT D · 2013 to 2023
$12.4M
ALTERED HEPATIC DISPOSITION OF ANIONIC DRUGS-MECHANISMSR01GM041935 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BROUWER, KIM L.R. · 1997 to 2016
$6.5M
Mechanisms of Altered Hepatic Transport: Impact on Drug TherapyR35GM122576 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER · 2017 to 2026
$5.7M
Predicting Intracellular Drug Concentrations In The Presence Of TransportersR01GM104178 · NIGMS · TEMPLE UNIV OF THE COMMONWEALTH · PI Kenneth Ray Korzekwa, Swati Nagar · 2013 to 2026
$4.0M
Improving prediction of drug interactions mediated by time-dependent inhibitorsR01GM114369 · NIGMS · TEMPLE UNIV OF THE COMMONWEALTH · PI KORZEKWA, KENNETH RAY, NAGAR, SWATI · 2016 to 2023
$3.2M
NIDA NIH HHS P01 DA032507NIGMS NIH HHS R01 GM041935NIGMS NIH HHS R01 GM104178NIGMS NIH HHS R01 GM114369NIGMS NIH HHS R35 GM122576
6 · The paper itself

Abstract

This white paper examines recent progress, applications, and challenges in predicting unbound and total tissue and intra/subcellular drug concentrations using in vitro and preclinical models, imaging techniques, and physiologically based pharmacokinetic (PBPK) modeling. Published examples, regulatory submissions, and case studies illustrate the application of different types of data in drug development to support modeling and decision making for compounds with transporter-mediated disposition, and likely disconnects between tissue and systemic drug exposure. The goals of this article are to illustrate current best practices and outline practical strategies for selecting appropriate in vitro and in vivo experimental methods to estimate or predict tissue and plasma concentrations, and to use these data in the application of PBPK modeling for human pharmacokinetic (PK), efficacy, and safety assessment in drug development.

Indexed as

Biological AssayIn Vitro TechniquesModels, BiologicalMolecular ImagingPharmacokineticsAnimalsCells, CulturedDrug DevelopmentHumansMembrane Transport ProteinsPharmaceutical PreparationsReproducibility of ResultsRisk AssessmentTissue DistributionMembrane Transport ProteinsPharmaceutical Preparations

Identifiers

PMID30059145
PMCPMC6197917

What OpenQuestion holds

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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.