Validation of Multivariate Outlier Detection Analyses Used to Identify Potential Drug-Induced Liver...
Validation of Multivariate Outlier Detection Analyses Used to Identify Potential Drug-Induced Liver Injury in Clinical Trial Populations
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Cham: Springer International Publishing
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Language
English
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Cham: Springer International Publishing
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Background:
Potential severe liver injury is identified in clinical trials by ALT >3 × upper limits of normal (ULN) and total bilirubin >2 × ULN, and termed ‘Hy’s Law’ by the US FDA. However, there is limited evidence or validation of these thresholds in clinical trial populations. Using liver chemistry data from clinical trials, decision bounda...
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Full title
Validation of Multivariate Outlier Detection Analyses Used to Identify Potential Drug-Induced Liver Injury in Clinical Trial Populations
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TN_cdi_proquest_miscellaneous_1221145822
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https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_1221145822
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ISSN
0114-5916
E-ISSN
1179-1942
DOI
10.1007/BF03261982
