Evidence map›Paper›PMID 41262067›Full record

ArticleClinical and translational science2025

Optimization of Bottom-Up PBPK Model Development in SIMCYP via Retrospective Analysis of Clinical Human PK Data.

Julia A Schulz Pauly, Alix F Leblanc, Ekram A Chowdhury, Yuli Qian, Leyla Rezaei, Christine M Lee, Mohamed Badawi, Ryota Kikuchi

Abstract read
In one paragraph

Article in Clinical and translational science, 2025. 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

8 authors.

Julia A Schulz PaulyQuantitative, Translational & ADME Sciences (QTAS), AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0002-6218-4023
Alix F LeblancQuantitative, Translational & ADME Sciences (QTAS), AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.ORCID 0000-0001-8667-103X
Ekram A ChowdhuryClinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.
Yuli QianClinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0002-8986-2189
Leyla RezaeiClinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0002-8818-6860
Christine M LeeClinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0001-6841-2747
Mohamed BadawiClinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0001-9033-2436
Ryota KikuchiQuantitative, Translational & ADME Sciences (QTAS), AbbVie Inc., North Chicago, Illinois, USA.ORCID 0009-0002-4889-8385

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Physiologically-based pharmacokinetic (PBPK) modeling has become a major tool in drug discovery and development. Here, we describe the bottom-up PBPK modeling approaches employed at AbbVie using Simcyp Simulator and evaluate the impact of three system parameters, GI physiology, P-gp Relative Expression Factor (REF), and recombinant CYP enzyme (rCYP) intersystem extrapolation factor (ISEF), independently and in combination, on PBPK prediction performance through retrospective analysis of 8 clinical assets. Overall, the application of New GI physiology resulted in a considerable improvement in the prediction of oral absorption for most compounds compared to the Original GI physiology (C

Indexed as

Models, BiologicalPharmacokineticsAdministration, OralArea Under CurveATP Binding Cassette Transporter, Subfamily B, Member 1Computer SimulationCytochrome P-450 Enzyme SystemHumansRetrospective StudiesATP Binding Cassette Transporter, Subfamily B, Member 1Cytochrome P-450 Enzyme Systembottom‐upGI physiologyISEFmodel performancePBPKP‐gp REF

Identifiers

PMID41262067
PMCPMC12631063

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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.