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KMID : 0379520060220020109
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한국독성학회지
2006 Volume.22 No. 2 p.109 ~ p.116
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Studies for the Guidance of Safety Pharmacology Studies in Compliance with Good Laboratory Practice
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Choi Ki-Hwan
Park Ki-Sook
Lee Yun-Hee
Na Han-Kwang
Yun Jae-Suk
Kim Dong-Sup
Kim Joo-II
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Abstract
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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.
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KEYWORD
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Safety pharmacology, GLP, ICH
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