Issue Date: April 8, 2008
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E15 Pharmacogenomics Definitions and Sample Coding
This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the International Conference on Harmonisation (ICH). This guidance on definitions is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes. As new scientific knowledge in the discipline of pharmacogenomics and pharmacogenetics emerges, the current guidance will be reviewed and expanded if appropriate.
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