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
in Chinese
| WPRIM
| ID: wpr-238582
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Product Surveillance, Postmarketing
/
Reference Standards
/
Drugs, Chinese Herbal
/
China
/
Epidemiology
/
Hospital Information Systems
/
Drug Monitoring
/
Drug-Related Side Effects and Adverse Reactions
/
Methods
Type of study:
Observational study
Limits:
Humans
Country/Region as subject:
Asia
Language:
Chinese
Journal:
China Journal of Chinese Materia Medica
Year:
2013
Type:
Article
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