Role of regulatory agencies in translating pharmacogenetics to the clinics

Prasad, Krishna (2009) Role of regulatory agencies in translating pharmacogenetics to the clinics. Clinical cases in mineral and bone metabolism, 6 (1). pp. 29-34. ISSN 1971-3266

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Overall, the regulators (here the term is used in the broad sense including competent authorities, the national departments of health and the European commission) have a significant role in translating pharmacogenomics into clinical practice. The first objective is to establish the role of the genomic information that is available, and this should be data driven. Conduct of robust clinical trials that are sound both scientifically and from a regulatory perspective should be encouraged. Significant interaction between Academia, Pharma industry and the regulator is essential with the overall aim of improving public health. Conceptually, this would involve the triumvirate (Academia, industry and regulators) as an orchestra with the regulators perhaps taking the role of the conductor while the significant players would be those that generate data (Academia and industry). The regulators also eed to ensure that clear guidance is available for use of the information and the tests with a significant level of uniformity between the ICH regions. The commercial availability of the test will have considerable impact on the use of pharmacogenomics, but this is currently beyond the scope of this paper.

Item Type: Article
Uncontrolled Keywords: Pharmacogenomics, drug regulation, pharmacogenetic testing, regulatory guidance, clinical practise
Subjects: 600 Tecnologia - Scienze applicate > 610 Medicina e salute (Classificare qui la tecnologia dei servizi medici) > 611 Anatomia; Citologia; Istologia umana > 611.7 Sistema muscoloscheletrico, tegumento
Depositing User: Danilo Dezzi
Date Deposited: 16 Jan 2014 14:40
Last Modified: 16 Jan 2014 14:40

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