Design and conduct of early phase drug studies in children: challenges and opportunities

Rieder, Michael and Hawcutt, Daniel ORCID: 0000-0002-8120-6507 (2016) Design and conduct of early phase drug studies in children: challenges and opportunities. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 82 (5). pp. 1308-1314.

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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.

Item Type:	Article
Uncontrolled Keywords:	children, clinical trials, drug development, early phase drug studies
Depositing User:	Symplectic Admin
Date Deposited:	13 Jul 2016 08:39
Last Modified:	19 Jan 2023 07:34
DOI:	10.1111/bcp.13058
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3002279