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KMID : 0861120130170030019
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Korean Journal of Oriental Preventive Medicine
2013 Volume.17 No. 3 p.19 ~ p.31
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Evidence-based approach for herbal medicine-safety classification : Human equivalent dose-based the margin of safety
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Park Yeong-Chul
Lee Sun-Dong
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Abstract
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This study was aimed to develop a new formula for herbal medicine-safety classification in terms of evidence-based medicine. Recently, human equivalent dose(HED)-based therapeutic index was developed for herbal medicine-safety classification by transforming LD50 to HED. However, the use of the ED50 and LD50 to derive the therapeutic index may be misleading as to safety, depending on the slope of the dose-response curves for therapeutic and lethal effects. To overcome this deficiency, HED-based MOS( Margin of Safety) was developed and suggested in this study. The HED-based MOS developed by using LD1, changing to ALD(approximate lethal dose), and ED99. The HED-based MOS seems to be more useful and safer than HED-based therapeutic index since its values for several herbal medicines are basically two times less than the values from HED-based therapeutic index. Thus, HED-based MOS can be a good example of Evidence-based approach for herbal medicine-safety classification.
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KEYWORD
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Herbal medicine, Safety classification, HED-based MOS, Evidence-based medicine
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