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Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine / 中国中药杂志
China Journal of Chinese Materia Medica ; (24): 3693-3696, 2015.
Article in Chinese | WPRIM | ID: wpr-320884
ABSTRACT
The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the appdsrisksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.
Subject(s)
Full text: Available Index: WPRIM (Western Pacific) Main subject: Patents as Topic / Product Surveillance, Postmarketing / Quality Control / Drugs, Chinese Herbal / Chemistry / Epidemiology / Clinical Trials as Topic / Herbal Medicine / Therapeutic Uses / Drug-Related Side Effects and Adverse Reactions Type of study: Health economic evaluation / Prognostic study Limits: Humans Language: Chinese Journal: China Journal of Chinese Materia Medica Year: 2015 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Patents as Topic / Product Surveillance, Postmarketing / Quality Control / Drugs, Chinese Herbal / Chemistry / Epidemiology / Clinical Trials as Topic / Herbal Medicine / Therapeutic Uses / Drug-Related Side Effects and Adverse Reactions Type of study: Health economic evaluation / Prognostic study Limits: Humans Language: Chinese Journal: China Journal of Chinese Materia Medica Year: 2015 Type: Article