Evidence map›Paper›PMID 41803558›Full record

ArticleThe AAPS journal2026

PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.

Gilbert J Burckart, Susan Abdel-Rahman, Caleb Choi, M Petrea Cober, James E Cummins, Nikoletta Fotaki, Daniel Gonzalez, David Harris, Neil Parrott, Hardikkumar Patel and 2 more

Abstract read
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In one paragraph

Article in The AAPS journal, 2026. 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

12 authors.

Gilbert J BurckartOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA. gilbert.burckart@fda.hhs.gov.ORCID 0000-0003-2005-9301
Susan Abdel-RahmanOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA.ORCID 0000-0002-5815-2029
Caleb ChoiOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA.ORCID 0009-0005-4882-6383
M Petrea CoberNortheast Ohio Medical University, College of Pharmacy, Rootstown, Ohio, USA.ORCID 0000-0002-4618-4998
James E CumminsNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0009-0003-2700-0051
Nikoletta FotakiUniversity of Bath, Bath, UK.ORCID 0000-0003-1826-7363
Daniel GonzalezSchoool of Medicine, Duke University, Durham, North Carolina, USA.ORCID 0000-0001-5522-5686
David HarrisMerck & Co., Inc, Rahway, New Jersey, USA.ORCID 0000-0001-9771-0866
Neil ParrottPredictive Modeling, Pharmaceutical Sciences, Roche Pharma Research and Early Development, Basel, Switzerland.ORCID 0000-0001-6821-7714
Hardikkumar PatelOffice of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-3855-5549
Fang WuDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0009-0009-1485-8386
Andreas AbendMerck & Co., Inc, Rahway, New Jersey, USA.ORCID 0000-0002-5638-9719

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In February of 2024, the Product Quality Research Institute held a virtual workshop entitled "Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development." The workshop covered a range of topics related to pediatric formulation development and testing, including dissolution testing and applications to modeling drug absorption in developing pediatric patients. Workshop speakers reviewed the progress that has been made to advance our understanding of ontogeny related processes that drive interactions with product formulations and inform pediatric product development. They discussed recently constructed pediatric biorelevant models that provide more realistic information about drug dissolution in pediatric patients and their use in physiologically based models to produce data for regulatory submissions. Despite the progress, opportunities remain to expand the fund of knowledge on pediatric absorptive processes that will support the development of pediatric-friendly drug formulations.

Indexed as

Drug DevelopmentModels, BiologicalPediatricsChemistry, PharmaceuticalChildHumansPharmaceutical PreparationsSolubilityPharmaceutical Preparationsbioequivalencebiorelevantoral formulationspediatricsphysiologically-based biopharmaceutics modeling

Identifiers

PMID41803558

What OpenQuestion holds

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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.