Evidence map›Paper›PMID 38720034›Full record

ArticlePharmaceutical research2024

Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value.

Ana L Coutinho, Rodrigo Cristofoletti, Fang Wu, Abdullah Al Shoyaib, Jennifer Dressman, James E Polli

Abstract read
In one paragraph

Article in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 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

6 authors.

Ana L CoutinhoDepartment of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 20 Penn Street, Room 623, HSF2 Building, Baltimore, MD, 21201, USA.ORCID http://orcid.org/0000-0002-3885-3709
Rodrigo CristofolettiDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, FL, USA.ORCID http://orcid.org/0000-0003-2619-0343
Fang WuOffice of Generic Drugs, Food and Drug Administration, White Oak, MD, USA.
Abdullah Al ShoyaibOffice of Generic Drugs, Food and Drug Administration, White Oak, MD, USA.
Jennifer DressmanFraunhofer Institute of Translational Medicine and Pharmacology, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
James E PolliDepartment of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 20 Penn Street, Room 623, HSF2 Building, Baltimore, MD, 21201, USA. jpolli@rx.umaryland.edu.ORCID http://orcid.org/0000-0002-5274-4314

Funding

Development and validation of a best practices framework for PBPK analysis for biopharmaceutic applications in support of model-informed biowaivers of fed state BE studies for BCS class II drugsU01FD007352 · FDA · UNIVERSITY OF FLORIDA · PI CRISTOFOLETTI, RODRIGO · 2021 to 2022
$600k
FDA HHS U01 FD007352U.S. Food and Drug Administration U01FD007352
6 · The paper itself

Abstract

purposeThe goal was to assess, for lipophilic drugs, the impact of logP on human volume of distribution at steady-state (VD

methodA sensitivity analysis with focus on logP was conducted by keeping pKa and fup constant for each of four drugs, while varying logP. VD

resultsThe Rodgers-Rowland methods were highly sensitive to logP values, followed by GastroPlus and Korzekwa-Nagar. The Oie-Tozer and TCM-New methods were only modestly sensitive to logP. Hence, the relative performance of these methods depended upon the source of logP value. As logP values increased, TCM-New and Oie-Tozer were the most accurate methods. TCM-New was the only method that was accurate regardless of logP value source. Oie-Tozer provided accurate predictions for griseofulvin, posaconazole, and isavuconazole; GastroPlus for itraconazole and isavuconazole; Korzekwa-Nagar for posaconazole; and TCM-New for griseofulvin, posaconazole, and isavuconazole. Both Rodgers-Rowland methods provided inaccurate predictions due to the overprediction of VD

conclusionsTCM-New was the most accurate prediction of human VD

Indexed as

Models, BiologicalHumansPharmaceutical PreparationsPharmacokineticsTissue DistributionTriazolesUncertaintyPharmaceutical PreparationsTriazoleslipophilicitylogPvolume of distribution

Identifiers

PMID38720034
PMCPMC11196289

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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.