Evidence map›Paper›PMID 33884497›Full record

SynthesisThe AAPS journal2021

Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products.

Gopal Pawar, Fang Wu, Liang Zhao, Lanyan Fang, Gilbert J Burckart, Kairui Feng, Youssef M Mousa, Franci Naumann, Hannah K Batchelor

Open access · hybridAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Optimizing Pediatric Drug Therapy: Pediatric Pharmacokinetics and Administration Routes.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 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

9 authors at 4 institutions in 2 countries.

Gopal PawarSchool of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Edgbaston, B15 2TT, UK. G.Pawar@bham.ac.uk.
Fang WuDivision of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA. Fang.Wu@fda.hhs.gov.
Liang ZhaoDivision of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Lanyan FangDivision of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Kairui FengDivision of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Youssef M MousaDivision of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Franci NaumannSchool of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.
Hannah K BatchelorStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow, G4 0RE, UK. Hannah.batchelor@strath.ac.uk.
United States Food and Drug Administration · USCenter for Drug Evaluation and Research · USUniversity of Birmingham · GBUniversity of Strathclyde · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Generally, bioequivalence (BE) studies of drug products for pediatric patients are conducted in adults due to ethical reasons. Given the lack of direct BE assessment in pediatric populations, the aim of this work is to develop a database of BE and relative bioavailability (relative BA) studies conducted in pediatric populations and to enable the identification of risk factors associated with certain drug substances or products that may lead to failed BE or different pharmacokinetic (PK) parameters in relative BA studies in pediatrics. A literature search from 1965 to 2020 was conducted in PubMed, Cochrane Library, and Google Scholar to identify BE studies conducted in pediatric populations and relative BA studies conducted in pediatric populations. Overall, 79 studies covering 37 active pharmaceutical ingredients (APIs) were included in the database: 4 bioequivalence studies with data that passed BE evaluations; 2 studies showed bioinequivalence results; 34 relative BA studies showing comparable PK parameters, and 39 relative BA studies showing differences in PK parameters between test and reference products. Based on the above studies, common putative risk factors associated with differences in relative bioavailability (DRBA) in pediatric populations include age-related absorption effects, high inter-individual variability, and poor study design. A database containing 79 clinical studies on BE or relative BA in pediatrics has been developed. Putative risk factors associated with DRBA in pediatric populations are summarized.

Indexed as

Models, BiologicalAdministration, OralAge FactorsArea Under CurveBiological AvailabilityChildClinical Trials as TopicCross-Over StudiesDatabases, PharmaceuticalDrug-Related Side Effects and Adverse ReactionsDrugs, GenericHumansRisk AssessmentRisk FactorsTherapeutic EquivalencyDrugs, Genericbioequivalenceoral productpediatricrelative bioavailabilityrisk factors

Identifiers

PMID33884497
PMCPMC8060189
OpenAlexW3154319338

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.