Mobilizing pharmacogenomic analyses during clinical trials in drug development.
Pharmacogenomics
; 14(10): 1227-35, 2013 Jul.
Article
en En
| MEDLINE
| ID: mdl-23859576
ABSTRACT
The utilization of pharmacogenomics (PGx) in drug development is increasing as pharmaceutical companies and regulatory agencies work to understand variation in response to medications. The implementation of PGx in clinical trials requires a number of considerations that begin early at the point of program development for a compound. This article will discuss the issues involved in mobilizing a PGx study during the conduct of a clinical trial, including the development of a PGx hypothesis, the identification of genetic markers for analysis, PGx platform selection and assay development, as well as challenges that arise in relation to global laws and regulations related to genetic research and logistical/timeline concerns in the execution of a PGx analysis.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Farmacogenética
/
Marcadores Genéticos
/
Descubrimiento de Drogas
Límite:
Humans
Idioma:
En
Revista:
Pharmacogenomics
Asunto de la revista:
FARMACOLOGIA
/
GENETICA MEDICA
Año:
2013
Tipo del documento:
Article
País de afiliación:
Estados Unidos