Evidence map›Paper›PMID 32698409›Full record

ArticlePharmaceutics2020

Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs.

John N Van den Anker, Susan McCune, Pieter Annaert, Gerri R Baer, Yeruk Mulugeta, Ramy Abdelrahman, Kunyi Wu, Kevin M Krudys, Jeffrey Fisher, William Slikker and 3 more

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

Article in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
28.8field-weighted citation impact, top 1% 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

15 citing papers in PubMed, 96 citations in OpenAlex.

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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

13 authors at 6 institutions in 4 countries.

John N Van den AnkerDivision of Clinical Pharmacology, Children's National Hospital, Washington, DC 20010, USA.
Susan McCuneOffice of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Pieter AnnaertDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.ORCID 0000-0003-3525-7351
Gerri R BaerOffice of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Yeruk MulugetaDivision of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Ramy AbdelrahmanDivision of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Kunyi WuOffice of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, MD 20993 USA.
Kevin M KrudysOffice of Neurosciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Jeffrey FisherNational Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USA.
William SlikkerNational Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USA.
Connie ChenHealth and Environmental Sciences Institute, Washington, DC 20005, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, MD 20993 USA.
Karel AllegaertDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.ORCID 0000-0001-9921-5105
United States Food and Drug Administration · USNational Center for Toxicological Research · USChildren's National · USErasmus MC · NLHealth and Environmental Sciences Institute · USKU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug dosing in neonates should be based on integrated knowledge concerning the disease to be treated, the physiological characteristics of the neonate, and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug. It is critically important that all sources of information be leveraged to optimize dose selection for neonates. Sources may include data from adult studies, pediatric studies, non-clinical (juvenile) animal models, in vitro studies, and in silico models. Depending on the drug development program, each of these modalities could be used to varying degrees and with varying levels of confidence to guide dosing. This paper aims to illustrate the variability between neonatal drug development programs for neonatal diseases that are similar to those seen in other populations (meropenem), neonatal diseases related but not similar to pediatric or adult populations (clopidogrel, thyroid hormone), and diseases unique to neonates (caffeine, surfactant). Extrapolation of efficacy from older children or adults to neonates is infrequently used. Even if a disease process is similar between neonates and children or adults, such as with anti-infectives, additional dosing and safety information will be necessary for labeling, recognizing that dosing in neonates is confounded by maturational PK in addition to body size.

Indexed as

dose findingdrug developmentneonatal clinical pharmacologynewbornpediatric drug delivery

Identifiers

PMID32698409
PMCPMC7408157
OpenAlexW3043246140

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.