Drug Development for Pediatric Populations: Regulatory Aspects

Drug Development for Pediatric Populations: Regulatory Aspects

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 particula...

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Bibliographic Details
Main Authors: Jochen Zisowsky, Jasper Dingemanse, Andreas Krause
Format: Article
Language:English
Published: MDPI AG 2010-11-01
Series:Pharmaceutics
Subjects:
pediatrics
children
pediatric drug development
pediatric legislation
health authorities
regulatory guidelines
PIP
clinical studies
Modeling and Simulation
PK/PD  modeling
Online Access:http://www.mdpi.com/1999-4923/2/4/364/

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http://www.mdpi.com/1999-4923/2/4/364/

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