Drug Development for Pediatric Populations: Regulatory Aspects
Open Access
- 29 November 2010
- journal article
- review article
- Published by MDPI AG in Pharmaceutics
- Vol. 2 (4), 364-388
- https://doi.org/10.3390/pharmaceutics2040364
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.This publication has 23 references indexed in Scilit:
- The role of population PK–PD modelling in paediatric clinical researchEuropean Journal of Clinical Pharmacology, 2010
- Proposals for model‐based paediatric medicinal development within the current European Union regulatory frameworkBritish Journal of Clinical Pharmacology, 2009
- Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspectiveChild and Adolescent Psychiatry and Mental Health, 2008
- Integrated??Pharmacokinetics??and Pharmacodynamics in??Drug??DevelopmentClinical Pharmacokinetics, 2007
- Population clinical pharmacology of children: general principlesEuropean Journal of Pediatrics, 2006
- Guidelines on Paediatric Dosing on the Basis of Developmental Physiology and Pharmacokinetic ConsiderationsClinical Pharmacokinetics, 2006
- Prediction of Cytochrome P450-Mediated Hepatic Drug Clearance in Neonates, Infants and ChildrenClinical Pharmacokinetics, 2006
- A Mechanistic Approach for the Scaling of Clearance in ChildrenClinical Pharmacokinetics, 2006
- Ontogeny of Hepatic and Renal Systemic Clearance Pathways in InfantsClinical Pharmacokinetics, 2002
- Optimal sampling times for pharmacokinetic experimentsJournal of Pharmacokinetics and Biopharmaceutics, 1981