Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments) / 中国中药杂志
China Journal of Chinese Materia Medica
; (24): 2919-2924, 2013.
Article
em Zh
| WPRIM
| ID: wpr-238582
Biblioteca responsável:
WPRO
ABSTRACT
It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.
Texto completo:
1
Base de dados:
WPRIM
Assunto principal:
Vigilância de Produtos Comercializados
/
Padrões de Referência
/
Medicamentos de Ervas Chinesas
/
China
/
Epidemiologia
/
Sistemas de Informação Hospitalar
/
Monitoramento de Medicamentos
/
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Métodos
Tipo de estudo:
Observational_studies
Limite:
Humans
País como assunto:
Asia
Idioma:
Zh
Ano de publicação:
2013
Tipo de documento:
Article