Evidence map›Paper›PMID 42082405›Full record

ReviewThe oncologist2026

Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products.

Ye Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, Youwei Bi, Olanrewaju Okusanya, Stacy Shord, Nam Atiqur Rahman, Brian Booth, Yangbing Li, Jiang Liu and 1 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The oncologist, 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

11 authors.

Ye XiongDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Robyn KonickiDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Jeanne Fourie ZirkelbachDivision of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Youwei BiDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Olanrewaju OkusanyaDivision of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Stacy ShordDivision of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Nam Atiqur RahmanDivision of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Brian BoothDivision of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Yangbing LiDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Jiang LiuDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Hao ZhuDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.ORCID 0000-0002-3858-2048

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Applying model-based approaches to leverage clinical and non-clinical data can support the identification of optimized dosage(s) for oncology products and allow for a better benefit-risk balance. In oncology, conventional dose-finding studies may lead to the selection of a poorly optimized dosage into subsequent studies, including those designed to demonstrate safety and efficacy in support of a marketing application. As a result, the clinical data obtained may be insufficient to optimize the benefit-risk profile of the drug without postmarketing studies. Model-informed drug development (MIDD), which includes modeling and simulation (eg, quantitative system pharmacology, empirical or mechanistic pharmacokinetic/pharmacodynamic models), and integrative exposure-response analysis, can significantly enhance dosage selection and optimization. This review provides an update on the recent utilization and unique challenges of MIDD for dosage optimization in oncology drug development.

Indexed as

Antineoplastic AgentsDrug DevelopmentNeoplasmsDose-Response Relationship, DrugHumansAntineoplastic Agentsdosage optimizationMIDDProject Optimus

Identifiers

PMID42082405
PMCPMC13153711

What OpenQuestion holds

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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.