Challenges in drug and biomarker co-development.
Recent Results Cancer Res
; 195: 229-39, 2012.
Article
en En
| MEDLINE
| ID: mdl-22527510
ABSTRACT
Co-development of drugs and biomarkers should be considered when the biomarker is intricately related to the use of the drug. There are risks and benefits to co-development and these need to be considered carefully early in the process. The current chapter attempts to delineate when it is appropriate to plan for co-development and to discuss a range of issues. Challenges include the determination of the type of assay (laboratory-developed test vs. reference laboratory vs. kit), the designs of trials for evaluation of clinical utility, and the regulatory pathway. Successful co-development requires planning very early in the process and assembling the appropriate multi-disciplinary team.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Diseño de Fármacos
/
Biomarcadores de Tumor
/
Neoplasias
/
Antineoplásicos
Límite:
Humans
Idioma:
En
Revista:
Recent Results Cancer Res
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos