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Pharmacogenetics regulation

Since Congress gave it authority to regulate in vitro diagnostic tests in 1976, the FDA has included assessment of clinical validity based on data made available by the test s developer (Holtzman, 2000). In view of the paucity of published data on predictive values of pharmacogenetic tests, and the likelihood that many of them will be low (Table 9.2), data on clinical validity should be required before pharmacogenetic tests are used clinically.12... [Pg.182]

VII. Do Genetic Tests for Predicting Risk of Disease Require More Regulation than Pharmacogenetic Tests ... [Pg.183]

Laurenzana EM, Hassett C, Omiecinski CJ. Post-transcriptional regulation of human microsomal epoxide hydrolase. Pharmacogenetics 1998 8 157-167. [Pg.244]

Johnson, A.D. Wang, D. Sadee, W. Polymorphisms affecting gene regulation and mRNA processing broad implications for pharmacogenetics. Pharmacol. Then 2005, 106, 19-38. [Pg.2799]


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Pharmacogenetic

Pharmacogenetics

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