Evidence map›Paper›PMID 30565653›Full record

Observational studyClinical pharmacology and therapeutics2019

Renal Clearance in Newborns and Infants: Predictive Performance of Population-Based Modeling for Drug Development.

Jian Wang, Shaun S Kumar, Catherine M Sherwin, Robert Ward, Gerri Baer, Gilbert J Burckart, Yaning Wang, Lynne P Yao

Open access · greenAbstract readObservational Study
In one paragraph

Observational study in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
6.9field-weighted citation impact, top 3% of its field
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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
    Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

8 authors at 4 institutions in 1 country.

Jian WangOffice of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Shaun S KumarDepartment of Pediatrics, Division of Clinical Pharmacology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Catherine M SherwinDepartment of Pediatrics, Division of Clinical Pharmacology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Robert WardDepartment of Pediatrics, Division of Clinical Pharmacology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Gerri BaerOffice of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Yaning WangOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Lynne P YaoDivision of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
University of Utah · USCenter for Drug Evaluation and Research · USUnited States Food and Drug Administration · USUnited Therapeutics (United States) · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The objective of this study was to evaluate the predictive performance of population models to predict renal clearance in newborns and infants. Pharmacokinetic (PK) data from eight drugs in 788 newborns and infants were used to evaluate the predictive performance of the population models based on postmenstrual age (PMA), postnatal age, gestational age, and body weight. For the PMA model, the average fold error for clearance (CL)

Indexed as

Models, BiologicalAmikacinBody WeightDrug DevelopmentFemaleForecastingGestational AgeGlomerular Filtration RateHeterocyclic CompoundsHumansInfantInfant, NewbornMaleMetabolic Clearance RateOrganometallic CompoundsRetrospective StudiesAmikacingadobutrolgadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetateHeterocyclic CompoundsOrganometallic CompoundsVancomycin

Identifiers

PMID30565653
PMCPMC6513721
OpenAlexW2905579940

What OpenQuestion holds

Textmetadata
LicenceTDM
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.