FDA perspectives on pharmacogenetic testing.
Expert Rev Mol Diagn
; 5(5): 643-8, 2005 Sep.
Article
em En
| MEDLINE
| ID: mdl-16149867
ABSTRACT
The field of pharmacogenetic testing is emerging as a topic of interest for many, due to its potential to improve patient care and optimize therapeutic development. The US Food and Drug Administration is interested in incorporating pharmacogenetics into development activities whenever appropriate to protect and promote public health. This article is intended to reflect the opinions of the Office of In vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health on some issues associated with developing in vitro diagnostic devices for use in pharmacogenetics. General points and potential issues related to the analytical and clinical validation of these types of devices will be discussed.
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Base de dados:
MEDLINE
Assunto principal:
Farmacogenética
/
United States Food and Drug Administration
Tipo de estudo:
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Expert Rev Mol Diagn
Assunto da revista:
BIOLOGIA MOLECULAR
Ano de publicação:
2005
Tipo de documento:
Article
País de afiliação:
Estados Unidos