• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

  • Print
  • Share
  • E-mail

Search Publications



Starting Date

Ending Date

Order by

Entry Details

Pharmaceutics 2020 Jul 20;12(7):E685

Approaches to dose finding in neonates, illustrating the variability between neonatal drug development programs.

Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, Abdelrahman R, Wu K, Krudys KM, Fisher J, Slikker W, Chen C, Burckart GJ, Allegaert K


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.

Category: Journal Article
PubMed ID: #32698409 DOI: 10.3390/pharmaceutics12070685
Includes FDA Authors from Scientific Area(s): Toxicological Research Women's Health Drugs
Entry Created: 2020-07-26