Evidence map›Paper›PMID 30865317›Full record

ArticleJournal of clinical pharmacology2019

Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.

Xiaomei I Liu, André Dallmann, Yow-Ming Wang, Dionna J Green, Janelle M Burnham, Beatrice Chiang, Perry Wu, Mark Sheng, Kelley Lu, John N van den Anker and 1 more

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

Article in Journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  4. Integrating Omics into Functional Biomarkers of Type 1 Diabetes.Cold Spring Harbor perspectives in medicine · 2024
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  15. Optimized lactoferrin as a highly promising treatment for intracerebral hemorrhage: Pre-clinical experience.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2021
    Article
  16. The Revolution in Pediatric Drug Development and Drug Use: Therapeutic Orphans No More.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020
    Article
  17. Article
  18. Article
  19. Review
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

11 authors at 6 institutions in 2 countries.

Xiaomei I LiuOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
André DallmannPediatric Pharmacology and Pharmacometrics Research Center, University Children's Hospital Basel (UKBB), Switzerland.
Yow-Ming WangOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Dionna J GreenOffice of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, MD, USA.
Janelle M BurnhamOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Beatrice ChiangSchool of Pharmacy, University of Southern California, Los Angeles, CA, USA.
Perry WuSchool of Pharmacy, University of Southern California, Los Angeles, CA, USA.
Mark ShengSchool of Pharmacy, University of Southern California, Los Angeles, CA, USA.
Kelley LuCollege of Pharmacy, University of Texas, Austin, TX, USA.
John N van den AnkerChildren's National Medical Center, Washington, DC, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Center for Drug Evaluation and Research · USUniversity of Southern California · USAustin College · USChildren's National · USUnited States Food and Drug Administration · USUniversity Children’s Hospital Basel · CH

Funding

Postdoctoral training in Pediatric Clinical PharmacologyT32HD087969 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2016 to 2020
$998k
NICHD NIH HHS T32 HD087969
6 · The paper itself

Abstract

The experience with the use of monoclonal antibodies and Fc-fusion proteins (mAb/Fc) in the pediatric population is limited. The objective of this study is to review those factors impacting the clinical efficacy and product safety of mAb/Fc products in pediatric patients during drug development. We reviewed the list of biologic products in the US Food and Drug Administration's Purple Book as of March 2018 with a focus on mAb/Fc products that are indicated for use in both adults and pediatric patients. Of 68 mAb/Fc products in the Purple Book (excluding biosimilars), 20 products have approved indications in both adults and children. Thirteen products had concurrent approval for both adult and pediatric populations. The sample size of pediatric studies generally ranged from approximately 2% to 70% of the sample size of adult studies with the same indication. In general, pediatric dosing regimens were found to be more based on body weight and weight tiered than the regimens for adults. Modeling and simulation techniques comprised mainly population pharmacokinetic and pharmacodynamic models. A review of the immunogenicity incidence did not reveal any notable difference in the 5 products having data on both pediatric and adult patients. In conclusion, most of the mAb/Fc products have a different weight-based dosing regimen for pediatric patients versus adults. An understanding of the comparative experience in drug development for mAb/Fc products between adult and pediatric patients coupled with the application of advanced modeling and simulation methods should assist future development of new mAb/Fc products for pediatric patients.

Indexed as

Receptors, FcAdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalBiological ProductsChildComputer SimulationDrug ApprovalHumansMiddle AgedModels, BiologicalRecombinant Fusion ProteinsUnited StatesUnited States Food and Drug AdministrationAntibodies, MonoclonalBiological ProductsReceptors, FcRecombinant Fusion Proteinsdosingdrug developmentFc-fusion proteinsimmunogenicitymodeling and simulationmonoclonal antibodiespediatrics

Identifiers

PMID30865317
PMCPMC6617747
OpenAlexW2921602098

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.