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Review
. 2017 Dec;64(6):1185-1196.
doi: 10.1016/j.pcl.2017.08.015.

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives

Yeruk Lily Mulugeta  1 , Anne Zajicek  2 , Jeff Barrett  3 , Hari Cheryl Sachs  4 , Susan McCune  4 , Vikram Sinha  5 , Lynne Yao  4
Affiliations
Review

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives

Yeruk Lily Mulugeta et al. Pediatr Clin North Am. 2017 Dec.

Abstract

Pediatric legislation has generated information about the efficacy, safety, and dosing of more than 600 products in children. Extrapolation of adult efficacy data has been an integral part of pediatric drug development. Advances in our understanding of physiology and pharmacology have improved the approach to pediatric dose selection. However, a high percentage of pediatric trials do not meet their primary efficacy endpoint. Delays in initiating completing pediatric studies persist. This article describes these advances and provides innovative approaches to optimize pediatric drug development.

Keywords: Dosing; Extrapolation; Neonatal; Pediatric; Regulations; Research.

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Figures

Fig. 1
Fig. 1
Pediatric labeling changes from 1998 to 2016.
See this image and copyright information in PMC

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