Next Article in Journal / Special Issue
Pediatric Dosing and Body Size in Biotherapeutics
Previous Article in Journal
Small Volume Dissolution Testing as a Powerful Method during Pharmaceutical Development
Previous Article in Special Issue
Timing and Duration of Drug Exposure Affects Outcomes of a Drug-Nutrient Interaction During Ontogeny
Pharmaceutics 2010, 2(4), 364-388; doi:10.3390/pharmaceutics2040364
Review

Drug Development for Pediatric Populations: Regulatory Aspects

* ,  and
Received: 15 October 2010 / Revised: 18 November 2010 / Accepted: 24 November 2010 / Published: 29 November 2010
View Full-Text   |   Download PDF [160 KB, 30 November 2010; original version 29 November 2010]   |   Browse Figure

Abstract

Pediatric aspects are nowadays integrated early in the development process of a new drug. The stronger enforcement to obtain pediatric information by the regulatory agencies in recent years resulted in an increased number of trials in children. Specific guidelines and requirements from, in particular, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) form the regulatory framework. This review summarizes the regulatory requirements and strategies for pediatric drug development from an industry perspective. It covers pediatric study planning and conduct, considerations for first dose in children, appropriate sampling strategies, and different methods for data generation and analysis to generate knowledge about the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug in children. The role of Modeling and Simulation (M&S) in pediatrics is highlighted—including the regulatory basis—and examples of the use of M&S are illustrated to support pediatric drug development.
Keywords: pediatrics; children; pediatric drug development; pediatric legislation; health authorities; regulatory guidelines; PIP; clinical studies; Modeling and Simulation; PK/PD  modeling pediatrics; children; pediatric drug development; pediatric legislation; health authorities; regulatory guidelines; PIP; clinical studies; Modeling and Simulation; PK/PD  modeling
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Share & Cite This Article

Further Mendeley | CiteULike
Export to BibTeX |
EndNote
MDPI and ACS Style

Zisowsky, J.; Krause, A.; Dingemanse, J. Drug Development for Pediatric Populations: Regulatory Aspects. Pharmaceutics 2010, 2, 364-388.

View more citation formats

Related Articles

Article Metrics

For more information on the journal, click here

Comments

Cited By

[Return to top]
Pharmaceutics EISSN 1999-4923 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert