Paediatrics Publications
Document Type
Article
Publication Date
1-1-2016
Journal
British Journal of Clinical Pharmacology
First Page
1308
Last Page
1314
URL with Digital Object Identifier
10.1111/bcp.13058
Abstract
It has historically been very difficult to conduct early phase drug studies in children for a number of reasons related to ethics, acceptability, rarity, standardization, end points, safety, dosing and feasibility. Over the past decade there have been a number of developments including novel clinical trial design, in silico pharmacology and microdosing that have significantly enhanced the ability of investigators to conduct early phase drug studies in children. While the evolution of drug therapy is creating a series of new challenges, there has never been a better time for conducting drug studies in children.