Evidence map›Paper›PMID 32542790›Full record

ArticleJournal of clinical pharmacology2020

Dosing Recommendations for Pediatric Patients With Renal Impairment.

Amer Al-Khouja, Kyunghun Park, Daijha J C Anderson, Caitlyn Young, Jian Wang, Shiew Mei Huang, Mona Khurana, Gilbert J Burckart

Abstract read
In one paragraph

Article in Journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. 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.

Amer Al-KhoujaDivision of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kyunghun ParkOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Daijha J C AndersonEshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
Caitlyn YoungUniversity of Southern California, Los Angeles, California, USA.
Jian WangOffice of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Shiew Mei HuangOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Mona KhuranaOffice of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-2005-9301

Funding

Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIGMS NIH HHS T32 GM066691
6 · The paper itself

Abstract

A treatment gap exists for pediatric patients with renal impairment. Alterations in renal clearance and metabolism of drugs render standard dosage regimens inappropriate and may lead to drug toxicity, but these studies are not routinely conducted during drug development. The objective of this study was to examine the clinical evidence behind current renal impairment dosage recommendations for pediatric patients in a standard pediatric dosing handbook. The sources of recommendations and comparisons included the pediatric dosing handbook (Lexicomp), the U.S. Food and Drug Administration-approved manufacturer's labels, and published studies in the literature. One hundred twenty-six drugs in Lexicomp had pediatric renal dosing recommendations. Only 14% (18 of 126) of Lexicomp pediatric renal dosing recommendations referenced a pediatric clinical study, and 15% of manufacturer's labels (19 of 126) described specific dosing regimens for renally impaired pediatric patients. Forty-two products had published information on pediatric renal dosing, but 19 (45%) were case studies. When pediatric clinical studies were not referenced in Lexicomp, the renal dosing recommendations followed the adult and pediatric dosing recommendations on the manufacturer's label. Clinical evidence in pediatric patients does not exist for most renal dosing recommendations in a widely used pediatric dosing handbook, and the adult renal dosing recommendations from the manufacturer's label are currently the primary source of pediatric renal dosing information.

Indexed as

PediatricsChildDatabases, FactualDrug Dosage CalculationsDrug Information ServicesDrug LabelingEvidence-Based MedicineFormularies as TopicHumansPractice Guidelines as TopicPrescription DrugsRenal InsufficiencyUnited StatesUnited States Food and Drug AdministrationPrescription Drugsdrug developmentMIDD (model-informed drug development)pediatrics (PED)renal diseasespecial populations

Identifiers

PMID32542790
PMCPMC8670561

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.