Background incidence of liver chemistry abnormalities in pediatric clinical trials for conditions with and without underlying liver disease

Heide A Stirnadel, Chanchal Bains, Mynepalli Lakshmi, Rakesh Pandey, David J Webb, Michael C Irizarry, Christine M Hunt

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

The FDA provides guidance regarding pre-marketing liver chemistry subject stopping criteria. This study was undertaken to determine the background rates of liver chemistry abnormalities in pediatric clinical trials for conditions with and without underlying liver disease (LD).
Original languageEnglish
Pages (from-to)329-35
Number of pages7
JournalRegulatory toxicology and pharmacology : RTP
Volume62
Issue number2
DOIs
Publication statusPublished - 2012

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