Toxicological Research

  • 제22권2호
  • /
  • Pages.109-116
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  • 2006
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  • 1976-8257(pISSN)
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  • 2234-2753(eISSN)
한국독성학회 (Korean Society of Toxicology & Korea Environmental Mutagen Society)
권호 표지

안전성약리시험의 Good Laboratory Practice 평가기술연구

Studies for the Guidance of Safety Pharmacology Studies in Compliance with Good Laboratory Practice

  • 최기환 (식품의약품안전청 국립독성연구원 일반약리팀) ;
  • 박기숙 (식품의약품안전청 국립독성연구원 일반약리팀) ;
  • 이윤희 (식품의약품안전청 국립독성연구원 일반약리팀) ;
  • 나한광 (식품의약품안전청 국립독성연구원 일반약리팀) ;
  • 윤재석 (식품의약품안전청 국립독성연구원 일반약리팀) ;
  • 김동섭 (식품의약품안전청 국립독성연구원 일반약리팀) ;
  • 김주일 (식품의약품안전청 국립독성연구원 일반약리팀)
  • Choi Ki-Hwan (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Park Ki-Sook (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Lee Yun-Hee (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Na Hang-Kwang (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Yun Jae-Suk (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Kim Dong-Sup (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Kim Joo-Il (Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
  • 발행 : 2006.06.01
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초록

Safety pharmacology studies are conducted to investigated the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In the International Conference on Harmonisation (ICH), the guideline 'S7A: Safety Pharmacology Studies for Human Pharmaceuticals' has been developed and reached Step 5 of the ICH process in 2001. Now the Korea Food and Drug Administration (KFDA) are going to transfer 'The Guideline for General Pharmacology' into 'The Guideline for Safety Pharmacology'. Safety pharmacology studies should be performed in compliance with Good Laboratory Practice (GLP). Thus, the present paper reviews the Japanese GLP guidelines for pharmaceuticals to help the conduct and inspection of safety pharmacology studies in compliance with GLP. We also reviewed the ICH guidelines 'S7B revised : The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals' and 'E14 : The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs' to apply our drug approval systems.

키워드

참고문헌

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