Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation.
Clin Pharmacol Ther
; 93(6): 515-25, 2013 Jun.
Article
en En
| MEDLINE
| ID: mdl-23571772
ABSTRACT
The "regulatory paradox" is a tension between aversion to uncertainty and willingness to accept unknowns about a drug before its approval. Finding the right balance may mean the difference between fostering and stifling innovation. Clinical pharmacology applied in the drug development and regulatory contexts can bridge mechanistic reasoning and empiricism to help reconcile the regulatory paradox. Here, we propose that the discipline of clinical pharmacology, in the regulatory setting, is well positioned to build on its past successes in the advancement and acceleration of drug development.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Farmacología Clínica
/
Aprobación de Drogas
/
Descubrimiento de Drogas
Tipo de estudio:
Prognostic_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Clin Pharmacol Ther
Año:
2013
Tipo del documento:
Article
País de afiliación:
Estados Unidos