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

doi:10.1016/j.yrtph.2011.10.013

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 journal › Article › peer-review

Abstract

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 language	English
Pages (from-to)	329-35
Number of pages	7
Journal	Regulatory toxicology and pharmacology : RTP
Volume	62
Issue number	2
DOIs	https://doi.org/10.1016/j.yrtph.2011.10.013
Publication status	Published - 2012

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@article{e0853f0e46814a04986faabdd54b4319,

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

abstract = "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).",

author = "Stirnadel, {Heide A} and Chanchal Bains and Mynepalli Lakshmi and Rakesh Pandey and Webb, {David J} and Irizarry, {Michael C} and Hunt, {Christine M}",

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doi = "10.1016/j.yrtph.2011.10.013",

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AU - Stirnadel, Heide A

AU - Bains, Chanchal

AU - Lakshmi, Mynepalli

AU - Pandey, Rakesh

AU - Webb, David J

AU - Irizarry, Michael C

AU - Hunt, Christine M

PY - 2012

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N2 - 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).

AB - 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).

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DO - 10.1016/j.yrtph.2011.10.013

M3 - Article

C2 - 22057095

SN - 1096-0295

VL - 62

SP - 329

EP - 335

JO - Regulatory toxicology and pharmacology : RTP

JF - Regulatory toxicology and pharmacology : RTP

IS - 2

ER -

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

Abstract

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