Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. [electronic resource]
- Drug safety Nov 2014
- S19-31 p. digital
Publication Type: Journal Article; Review
1179-1942
10.1007/s40264-014-0183-6 doi
Animals Biomarkers--metabolism Chemical and Drug Induced Liver Injury--diagnosis Clinical Trials as Topic--methods Data Collection--methods Drug-Related Side Effects and Adverse Reactions--diagnosis Humans Metabolomics--methods Pharmacogenetics--methods Proteomics--methods Research Design Risk Assessment--methods United States United States Food and Drug Administration