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Design and conduct of early phase drug studies in children: challenges and opportunities
Author(s) -
Rieder Michael,
Hawcutt Daniel
Publication year - 2016
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.13058
Subject(s) - drug , standardization , dosing , medicine , pharmacology , clinical study design , clinical trial , drug development , phase (matter) , intensive care medicine , engineering ethics , computer science , engineering , pathology , chemistry , organic chemistry , operating system
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.