[How to improve drug development and utilization in pediatrics]. / Comment mieux développer et utiliser les médicaments en pédiatrie?
Therapie
; 54(4): 423-32, 1999.
Article
en Fr
| MEDLINE
| ID: mdl-10667109
ABSTRACT
Insufficient drug evaluation in children and the lack of adapted pharmaceutical formulations explain the importance of unlicensed and off-label prescriptions. As a consequence a regulation proposed in the USA by the Food and Drug Administration, requiring manufactures to assess the safety and effectiveness of new drugs in paediatric patients, has recently been adopted. Appropriate means to facilitate drug evaluation in children are now necessary in terms of recruitment and methodology. A ten-centre American Pediatric Pharmacology Research Unit network has been created and is being financed by the National Institute of Health. A similar trend is evolving in Europe. Appropriate drug utilization in children requires adequate formulations, administration devices and information as well as improved knowledge on the long-term potential consequences of drug use during growth and maturation.
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Bases de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
/
Diseño de Fármacos
/
Evaluación de Medicamentos
/
Utilización de Medicamentos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Child
/
Humans
País/Región como asunto:
America do norte
/
Europa
Idioma:
Fr
Revista:
Therapie
Año:
1999
Tipo del documento:
Article
País de afiliación:
Francia