Evidence map›Paper›PMID 31963448›Full record

ArticlePharmaceutics2020

A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP.

Marival Bermejo, Bart Hens, Joseph Dickens, Deanna Mudie, Paulo Paixão, Yasuhiro Tsume, Kerby Shedden, Gordon L Amidon

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
4.2field-weighted citation impact, top 5% 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

20 citing papers in PubMed, 68 citations in OpenAlex.

  1. Trial
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  10. The [Lipids · 2022
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  14. Acta pharmaceutica Sinica. B · 2021
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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

8 authors at 4 institutions in 4 countries.

Marival BermejoDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.ORCID 0000-0001-5022-0544
Bart HensDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.ORCID 0000-0002-4229-9843
Joseph DickensDepartment of Statistics, University of Michigan, Ann Arbor, MI 48109, USA.
Deanna MudieDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.ORCID 0000-0002-3586-5069
Paulo PaixãoDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.
Yasuhiro TsumeDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.
Kerby SheddenDepartment of Statistics, University of Michigan, Ann Arbor, MI 48109, USA.
Gordon L AmidonDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.
University of Michigan · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USUniversitat de Miguel Hernández d'Elx · ESUniversity of Lisbon · PT

Funding

Fonds Wetenschappelijk Onderzoek 12R2119NU.S. Food and Drug Administration HHSF223201310144CU.S. Food and Drug Administration HHSF223201510157C
6 · The paper itself

Abstract

The application of in silico modeling to predict the in vivo outcome of an oral drug product is gaining a lot of interest. Fully relying on these models as a surrogate tool requires continuous optimization and validation. To do so, intraluminal and systemic data are desirable to judge the predicted outcomes. The aim of this study was to predict the systemic concentrations of ibuprofen after oral administration of an 800 mg immediate-release (IR) tablet to healthy subjects in fasted-state conditions. A mechanistic oral absorption model coupled with a two-compartmental pharmacokinetic (PK) model was built in Phoenix WinNonlinWinNonlin

Indexed as

clinical studiesgastrointestinalGastroPlusibuprofenin silico modelingmanometrymechanistic modelingoral absorptionPBBMPBPKpharmacokineticsPhoenix WinNonlin

Identifiers

PMID31963448
PMCPMC7023481
OpenAlexW3000135183

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.