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KMID : 1142220090040010051
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.51 ~ p.58
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Study on the Safety Pharmacology Guideline for Global Harmonization
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Ahn Joon-Ik
Cha Hye-Jin
Jeong Ho-Sang
Kim Eun-Jung
Cho Hea-Young
Kim Hye-Soo
Jung Eun-Yong
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Abstract
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The drug development is tremendous amount of time and money consuming works. Nevertheless, blockbuster drugs have withdrawn from markets by unwanted effects and it has been issued around the world, recently. In drug development, the pharmaceutical company as well as the regulatory agency have been concerning drug safety significantly. US, Europe, and Japan agreed to implement the ICH guideline for safety pharmacology and has conducted this study during drug development. Korea Food and Drug Administration (KFDA) drew up safety pharmacology guideline following ICH S7A and S7B - the safety pharmacology guideline according to Korea's condition. It could be expected to help understanding safety pharmacology for pharmaceutical companies and non clinical CROs (contract research organizations).
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KEYWORD
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Safety pharmacology, ICH, Guideline, Drug development
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