한국식품위생안전성학회지 (Journal of Food Hygiene and Safety)

  • 제26권4호
  • /
  • Pages.302-307
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  • 2011
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  • 1229-1153(pISSN)
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  • 2465-9223(eISSN)
한국식품위생안전성학회 (The Korean Society of Food Hygiene and Safety)
권호 표지

건강기능식품 부작용 원인분석을 위한 알고리즘

Algorithms for Causality Evaluation of Adverse Events from Health/Functional Foods

  • 이경진 (위해정보과, 식품의약품안전청) ;
  • 박경식 (건강기능식품기준과, 식품의약품안전청) ;
  • 김정훈 (영양기능연구팀, 식품의약품안전평가원) ;
  • 이영주 (영양기능연구팀, 식품의약품안전평가원) ;
  • 윤태형 (영양기능연구팀, 식품의약품안전평가원) ;
  • 노기미 (영양기능연구팀, 식품의약품안전평가원) ;
  • 박미선 (영양기능연구팀, 식품의약품안전평가원) ;
  • 임동길 (영양기능연구팀, 식품의약품안전평가원) ;
  • 윤창용 (영양기능연구팀, 식품의약품안전평가원) ;
  • 정자영 (영양기능연구팀, 식품의약품안전평가원)
  • Lee, Kyung-Jin (Risk Information Division, Korea Food & Drug Administration) ;
  • Park, Kyoung-Sik (Functional Food Standards Division, Korea Food & Drug Administration) ;
  • Kim, Jeong-Hun (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • Lee, Young-Joo (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • Yoon, Tae-Hyung (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • No, Ki-Mi (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • Park, Mi-Sun (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • Leem, Dong-Gil (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • Yoon, Chang-Yong (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation) ;
  • Jeong, Ja-Young (Nutrition and Functional Food Research Team, National Institute of Food & Drug Safety Evaluation)
  • 투고 : 2011.08.19
  • 심사 : 2011.11.08
  • 발행 : 2011.12.31
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초록

One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M & V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.

키워드

참고문헌

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