Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 2904-2906, 2011.
Artigo
em Chinês
| WPRIM
| ID: wpr-293155
ABSTRACT
In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Vigilância de Produtos Comercializados
/
Tamanho da Amostra
/
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Medicina Tradicional Chinesa
Tipo de estudo:
Estudo diagnóstico
Limite:
Humanos
Idioma:
Chinês
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2011
Tipo de documento:
Artigo
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