Evidence mapPaperPMID 41174355Full record

ReviewClinical pharmacology and therapeutics2026

Model-Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia.

Kelly M Mahar, Shuying Yang, Brendan Johnson, Sandra A G Visser, Paul van den Berg, Martijn van Noort, Teun M Post

Abstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 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

7 authors.

Kelly M MaharGSK, Collegeville, Pennsylvania, USA.ORCID 0000-0002-7698-2149
Shuying YangGSK, London, UK.ORCID 0000-0001-9841-2342
Brendan JohnsonGSK, Durham, North Carolina, USA.ORCID 0000-0003-3737-7146
Sandra A G VisserGSK, Collegeville, Pennsylvania, USA.ORCID 0009-0008-2186-7195
Paul van den BergLeiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.ORCID 0000-0003-2241-3001
Martijn van NoortLeiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.ORCID 0009-0004-7016-2846
Teun M PostLeiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.ORCID 0000-0001-9183-2678

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Model-informed drug development (MIDD) played a crucial role in the successful development and regulatory approval of daprodustat, a novel oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor aimed at treating anemia in chronic kidney disease patients. MIDD was pivotal in optimizing dosing strategies and enabling effective dose individualization, ensuring the right dose for the right patient. This tutorial illustrates how integrated quantitative approaches, including longitudinal hemoglobin response modeling, population pharmacokinetics (PopPK), and clinical trial simulations, were applied to guide phase III dose selection, inform trial design, and support regulatory interactions. We highlight the evolution and application of these models, emphasizing key development decisions, challenges encountered, and insights gained.

Indexed as

AnemiaBarbituratesDrug DevelopmentGlycineModels, BiologicalProlyl-Hydroxylase InhibitorsRenal Insufficiency, ChronicClinical Trials, Phase III as TopicComputer SimulationDose-Response Relationship, DrugHemoglobinsHumansHypoxia-Inducible Factor-Proline DioxygenasesPrecision MedicineBarbituratesGlycineGSK1278863HemoglobinsHypoxia-Inducible Factor-Proline DioxygenasesProlyl-Hydroxylase Inhibitors

Identifiers

PMID41174355
PMCPMC12816422

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.