Analysis of clinical trials and off-label drug use in hospitalized pediatric patients. / Analysis of clinical trials and off-label drug use in hospitalized pediatric patients.
Arch Argent Pediatr
; 112(3): 249-53, 2014 Jun.
Artigo
em Espanhol
| BINACIS
| ID: bin-133573
ABSTRACT
Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed childrens hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26
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Texto completo:
Disponível
Coleções:
Bases de dados internacionais
/
Bases de dados nacionais
/
Argentina
Base de dados:
BINACIS
/
LILACS
Assunto principal:
Ensaios Clínicos como Assunto
/
Uso Off-Label
/
Hospitalização
Tipo de estudo:
Estudo observacional
/
Ensaio clínico controlado
Limite:
Criança
/
Humanos
Idioma:
Espanhol
/
Inglês
Revista:
Arch Argent Pediatr
/
Arch. argent. pediatr
Assunto da revista:
Pediatria
Ano de publicação:
2014
Tipo de documento:
Artigo
País de afiliação:
Espanha
Instituição/País de afiliação:
Hospital Universitario La Paz/ES