A proposed modification to Hy's law and Edish criteria in oncology clinical trials using aggregated historical data
Pharmacoepidemiology and Drug Safety2013Vol. 22(6), pp. 571–578
Citations Over TimeTop 11% of 2013 papers
Daniel Parks, Xiwu Lin, Jeffery L. Painter, Jie Cheng, Christine M. Hunt, Colin F. Spraggs, Jeanenne J. Nelson, Lloyd Curtis, J. Alan Menius, Kwan R. Lee
Abstract
These higher liver chemistry thresholds examining fold-ULN and fold-baseline data may be valuable in identifying potential severe liver injury and detecting liver safety signals of clinical concern in oncology clinical trials and postapproval settings while helping to avoid premature discontinuation of curative therapy.
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