Studies for the Guidance of Safety Pharmacology Studies in Compliance with Good Laboratory Practice
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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) |
1 | ICH Harmonized Tripartite Guideline (1997): Timing of nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals (M3) |
2 | ICH Harmonized Tripartite Guideline (S7A). Safety pharmacology studies for human pharmaceuticals (2001) |
3 | 식품의약품안전청 (2000): 비임상시험관리기준 식품의약품안전청 고시 제2000-63호 (2000. 12. 11.) |
4 | Cavero, I. and Crumb, W. (2005): ICH S7B draft guideline on the non-clinical strategy for testing delayed caridac repolarisation risk of drugs: a critical analysis. Expert Opin. Drug Saf., 4, 509-530 DOI ScienceOn |
5 | Friedrichs, G.S., Patmore, L. and Bass, A. (2005): Non-clinical evaluation of ventricular repolarization (ICH S7B): results of an interim survey of international pharmaceutical companies. J. Pharmacol. Toxicol. Methods, 51, 6-11 |
6 | Gallo, M.A. (2001): History and Scope of Toxicology in Casarett and Doull's Toxicology: the Basic Science of Poisons, 6th Ed (C.D. Klaassen, Ed.), McGrow-Hill, New York, pp. 3-10 |
7 | 국립독성연구원 일반약리과 (2004) : 안전성약리시험 자료집 III - ICH Guidelines for Safety Pharmacology Study |
8 | 국립독성연구원 일반약리과 (2004) : 안전성약리시험 자료집 IV - 안전성약리시험에 대한 일본의약품 GLP평가 자료집 |
9 | ICH Harmonized Tripartite Guideline (2005). The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14) |
10 | Choi, K.H., Park, I.S., Lim, H.K., Oh, W.Y., Wang, S.Y., Kim, S.H., Kim, J.I. and Kim, D.S. (2003): Drug development and guideline for safety pharmacology studies. Yakhak Hoeji, 47, 104-109 |
11 | 국립독성연구원 일반약리과 (2004): 안전성약리시험 자료집 I - IQPC Safety Pharmacology Conference & Workshop |
12 | Valentin, J.P., Bass, A.S., Atrakchi, A., Olejniczak, K. and Kannosuke, F. (2005): Challenges and lessons learned since implementation of the safety. J. Pharmacol. Toxicol. Methods, 52, 22-29 DOI ScienceOn |
13 | ICH Harmonized Tripartite Guideline (2005). The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals (S7B) |
14 | Paakkari, I. (2002): Cardiotoxicity of new antihistamines and cisapride. Toxicol. Lett., 127, 279-284 DOI ScienceOn |
15 | 일본 의약품 GLP Q&A집 편집위원회 (2003): 의약품 GLP Q&A집 |
16 | 국립독성연구원 일반약리과 (2004) : 안전성약리시험 자료집 II - Safety Pharmacology Society 4th Annual Meeting |
17 | 일본후생노동성 (Japanese Ministry of Health, Labor and Welfare) (2001): 安全性藥理試驗 가이드라인 藥審發 第 902 (2001. 6. 21.) |
18 | ICH Harmonized Tripartite Guideline (1997): Preclinical safety evaluation of biotechnology-derived pharmaceuticals (M6) |
19 | (재)일본약제사연수센타 (2004): 의약품 GLP 가이드라인 |
20 | Shah, R.R. (2005): Drugs, QTc interval prolongation and final ICH E14 guideline : an important milestone with challenges ahead. Drug Saf., 28, 1009-1028 DOI ScienceOn |
21 | 식품의약품안전청 (1998): 의약품 등의 일반약리시험 지침 식품의 약품안전청고시 제1998-62호 (1998. 5. 29) |
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