의약품 부작용에 관한 국제 분류체계인 WHO-ART와 MedDRA의 비교분석
Comparison of WHO-ART Versus MedDRA, Internationally Standardized Terminology of Adverse Drug Reaction Classification
  • 임경화
  • 신현택
  • 손현순
  • 전효정
  • 이주현
  • 외 3명
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초록

This study was aimed to provide the controlled terminology for adverse drug reactions by selecting an appropriate internationally standardized classifications (WHO-ART or MedDRA). We collected the relevant information on ADR terminology systems including WHO-ART and MedDRA by online searching and visiting pharmaceutical companies and WHO UMC (Uppsala Monitoring Centre, Uppsala, Sweden). For MedDRA, project leader directly communicated with the officer of MSSO (Maintenance and Support Services Organization). Collecting all the pertinent information, two possible terminology classifications or systems (WHO-ART and MedDRA) were compared in the views of acceptability, cost-effectiveness and international feasibility and reviewed by the consultation committee and finally WHO-ART was selected.

키워드

DrugADR(Adverse Drug Reaction)TerminologyWHO-ARTMedDRA
제목
의약품 부작용에 관한 국제 분류체계인 WHO-ART와 MedDRA의 비교분석
제목 (타언어)
Comparison of WHO-ART Versus MedDRA, Internationally Standardized Terminology of Adverse Drug Reaction Classification
저자
임경화신현택손현순전효정이주현이유정이영숙송인숙
발행일
2007-06
저널명
한국임상약학회지
17
1
페이지
46 ~ 52