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

Pharmaceutics
John N Van den AnkerKarel Allegaert

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,...Continue Reading

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Citations

Jan 6, 2021·Pharmaceutics·Miriam AyusoSteven Van Cruchten
Jan 21, 2021·International Journal of Environmental Research and Public Health·Tamara van DongeKarel Allegaert
Jun 30, 2021·Journal of Clinical Pharmacology·John van den Anker, Karel Allegaert
Jun 30, 2021·Journal of Clinical Pharmacology·Gilbert J Burckart, John N van den Anker
Jun 30, 2021·Journal of Clinical Pharmacology·Karel Allegaert, John van den Anker
Jun 30, 2021·Journal of Clinical Pharmacology·Jian WangGilbert J Burckart

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Methods Mentioned

BETA
pharmacotherapy
genotyping

Software Mentioned

CLARINET

Related Concepts

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