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Drug Development for Pediatric Populations: Regulatory Aspects
Actelion Pharmaceuticals Ltd, Clinical Pharmacology, Gewerbestrasse 16, CH-4123 Allschwil, Switzerland
* Author to whom correspondence should be addressed.
Received: 15 October 2010; in revised form: 18 November 2010 / Accepted: 24 November 2010 / Published: 29 November 2010
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
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MDPI and ACS Style
Zisowsky, J.; Krause, A.; Dingemanse, J. Drug Development for Pediatric Populations: Regulatory Aspects. Pharmaceutics 2010, 2, 364-388.
Zisowsky J, Krause A, Dingemanse J. Drug Development for Pediatric Populations: Regulatory Aspects. Pharmaceutics. 2010; 2(4):364-388.
Zisowsky, Jochen; Krause, Andreas; Dingemanse, Jasper. 2010. "Drug Development for Pediatric Populations: Regulatory Aspects." Pharmaceutics 2, no. 4: 364-388.