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Review
. 2019 Jul;36(S 02):S18-S21.
doi: 10.1055/s-0039-1691772. Epub 2019 Jun 25.

Neonatal Therapeutics: Considerations for Dosing

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Review

Neonatal Therapeutics: Considerations for Dosing

Kanecia O Zimmerman et al. Am J Perinatol. 2019 Jul.

Abstract

Neonates are a uniquely vulnerable population, compromised by immature physiology and critical illness if born premature. Furthermore, neonates have frequent exposures to drugs that lack adequate data on safety, efficacy, and appropriate dosing in this population. Key physiologic differences between neonates and older children and adults affect drug absorption, distribution, metabolism, and elimination. Adequate understanding and consideration of these differences is essential to ensure optimal dosing of therapeutic agents in this vulnerable population. Moreover, direct study of neonates through appropriately designed pharmacokinetic and pharmacodynamic studies can ensure the development of safe and effective therapeutics in our youngest populations of patients.

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Conflict of interest statement

K.O.Z. receives support from the National Institutes of Health (National Institute of Child Health and Human Development (K23 HD091398, HHSN275201000003I), the Duke Clinical and Translational Science Award (KL2TR001115-03), and industry for neonatal and pediatric drug development, www.dcri.duke.edu/research/coi.jsp. D.K.B. Jr. receives support from the National Institutes of Health (award 2K24HD058735-10, National Institute of Child Health and Human Development (HHSN275201000003I), National Institute of Allergy and Infectious Diseases (HHSN272201500006I), ECHO Program (1U2COD023375-02), and the National Center for Advancing Translational Sciences (1U24TR001608-03); he also receives research support from Cempra Pharmaceuticals (subaward to HHSO100201300009C) and industry for neonatal and pediatric drug development, www.dcri.duke.edu/research/coi.jsp. M.L.B. receives support from the National Institutes of Health (National Institute of Child Health and Human Development [R01HD089928] and the National Center for Advancing Translational Sciences [1U24TR001608-03]); she also has a consulting agreement in place with Swedish Orphan Biovitrum for pharmacokinetic consultation for anakinra in the pediatric population.

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