Restricted accessOtherFirst published online 2006-1
Pharmacogenomic Testing and Regulation: The Role of Pharmacogenomics in Pharmaceutical Development and the Regulation of Pharmacogenetic Test as in Vitro Diagnostics *
This article reviews the current role and future trends of pharmacogenomic testing in pharmaceutical development and postmarketing surveillance. The regulatory controls operating in Europe and the United States are described and compared. It is suggested that codevelopment of the diagnostic test should be considered as an integral part of the drug development program. The regulatory controls of the pharmacogenetic test and the drug need to be better aligned. Integration of patient and professional information is required. International standards are required for “traceability.”
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