Evidence map›Paper›PMID 27040726›Full record

SynthesisJournal of clinical pharmacology2016

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.

Yeruk Mulugeta, Jeffrey S Barrett, Robert Nelson, Abel Tilahun Eshete, Alvina Mushtaq, Lynne Yao, Nicole Glasgow, Andrew E Mulberg, Daniel Gonzalez, Dionna Green and 6 more

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
–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

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  6. Strategies for pediatric dose derivation from population pharmacokinetic models.Journal of pharmacokinetics and pharmacodynamics · 2026
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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

16 authors.

Yeruk MulugetaOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Jeffrey S BarrettDivision of Clinical Pharmacology & Therapeutics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Robert NelsonOffice of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
Abel Tilahun EsheteOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Alvina MushtaqChildren's National Medical Center, Washington, DC, USA.
Lynne YaoPediatric and Maternal Health Staff, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Nicole GlasgowUniversity of Maryland School of Pharmacy, Baltimore, MD, USA.
Andrew E MulbergDivision of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.
Dionna GreenOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Jeffry FlorianOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kevin KrudysOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Shirley SeoOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Insook KimOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Dakshina ChilukuriOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. gilbert.burckart@fda.hhs.gov.

Funding

Use of Physiologically-Based PK/PD Models to Streamline Drug ApprovalsK23HD083465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GONZALEZ, DANIEL · 2015 to 2019
$727k
Intramural FDA HHS FD999999NICHD NIH HHS K23 HD083465
6 · The paper itself

Abstract

During drug development, matching adult systemic exposures of drugs is a common approach for dose selection in pediatric patients when efficacy is partially or fully extrapolated. This is a systematic review of approaches used for matching adult systemic exposures as the basis for dose selection in pediatric trials submitted to the US Food and Drug Administration (FDA) between 1998 and 2012. The trial design of pediatric pharmacokinetic (PK) studies and the pediatric and adult systemic exposure data were obtained from FDA publicly available databases containing reviews of pediatric trials. Exposure-matching approaches that were used as the basis for pediatric dose selection were reviewed. The PK data from the adult and pediatric populations were used to quantify exposure agreement between the 2 patient populations. The main measures were the pediatric PK studies' trial design elements and drug systemic exposures (adult and pediatric). There were 31 products (86 trials) with full or partial extrapolation of efficacy with an available PK assessment. Pediatric exposures had a range of mean C

Indexed as

United States Food and Drug AdministrationAdultAge FactorsChildClinical Trials as TopicDose-Response Relationship, DrugDrug DiscoveryHumansPharmaceutical PreparationsTreatment OutcomeUnited StatesPharmaceutical Preparationsdosingdrug developmentexposure matchingextrapolationpediatrics

Identifiers

PMID27040726
PMCPMC5482171

What OpenQuestion holds

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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.