Clinical report--guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations.

Abstract:

:The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Shaddy RE,Denne SC,Committee on Drugs and Committee on Pediatric Research.

doi

10.1542/peds.2010-0082

subject

Has Abstract

pub_date

2010-04-01 00:00:00

pages

850-60

issue

4

eissn

0031-4005

issn

1098-4275

pii

peds.2010-0082

journal_volume

125

pub_type

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