Evidence map›Paper›PMID 42050771›Full record

ReviewClinical and translational science2026

From Models to Medicines: A Narrative History and Regulatory Perspective on the Translational Impact of Model-Informed Drug Development (MIDD).

Issam Zineh

Abstract readHistorical ArticleReview
In one paragraph

Review in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

1 author.

Issam ZinehOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Model-informed drug development (MIDD) has grown from a constellation of methodological advances to a profound reorientation of how evidence is generated, evaluated, integrated, and leveraged in both drug development and regulatory decision-making. Over decades, pharmaco-statistical modeling and simulation (M&S) have moved from supplemental analyses toward shared frameworks for quantitative and mechanistic reasoning on questions as diverse as clinical trial planning, effectiveness and drug safety risk assessment, and therapeutic optimization. This perspective traces that evolution and argues that MIDD's translational promise lies not only in ever-increasing technical sophistication, but in its capacity to reshape how we talk about how medicines are developed, evaluated, and optimized for patients.

Indexed as

Drug DevelopmentTranslational Research, BiomedicalHistory, 20th CenturyHistory, 21st CenturyHumans

Identifiers

PMID42050771
PMCPMC13124653

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.