Subject: Hy’s Law | RM1-950 | GGT | Therapeutics. Pharmacology | bilirubin | ALT | prediction | Drug Design, Development and Therapy | Original Research | baseline
Zhaohui Cai,1,* Anders Bresell,2,* Mark H Steinberg,1 Debra G Silberg,1 Stephen T Furlong11AstraZeneca Pharmaceuticals, Wilmington, DE, USA; 2AstraZeneca Pharmaceuticals, S&ouml;dert&auml;lje, Sweden*These authors contributed equally to this workPurpose: The goa... View more
1. Food and Drug Administration. Guidance for Industry. Drug-Induced Liver Injury: Premarketing clinical evaluation.Available from: http://www. fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM174090.pdf. Accessed November 9, 2012.
2. Temple R. Hy's law. Predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15(4):241-243.
3. Reuben A. Landmarks in hepatology. Hepatology. 2004;40:1478-1482.
4. Cai Z, Christianson AM, Ståhle L, Keisu M. Reexamining transaminase elevation in Phase I clinical trials: the importance of baseline and change from baseline. Eur J Clin Pharmacol. 2009;65:1025-1035.
5. Clinical Data Interchange Standards Consortium. CDISC Study Data Tabulation Model. SDTM Implementation Guide V3.1.1. Available from: http://www.cdisc.org/models/sdtm/v1.1/index.html. Accessed February 12, 2009.
6. Breiman L. Random forests. Mach Learning. 2001;45:5-32.
7. Weil JG, Bains C, Linke A, Clark DW, Stirnadel HA, Hunt CM. Background incidence of liver chemistry abnormalities in a clinical trial population without underlying liver disease. Regul Toxicol Pharmacol. 2008;52:85-88.
8. Xu Y, Bi YF, Xu M, et al. Cross-sectional and longitudinal association of serum alanine aminotransaminase and γ-glutamyltransferase with metabolic syndrome in middle-aged and elderly Chinese people. J Diabetes. 2011;3:38-47.
9. George J, Denney-Wilson E, Okely AD, Hardy LL, Aitken R. The population distributions, upper normal limits and correlations between liver tests among Australian adolescents. J Pediatr Child Health. 2008;44:579-585.
10. Critical Path Institute. Predictive Safety Testing Consortium. Available from: http://www.c-path.org/pstc.cfm. Accessed February 27, 2011.