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KMID : 1142220100050010065
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.65 ~ p.71
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The Study on Follow-up and Supplemental Safety Pharmacology
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Na Han-Sung
Shin Hee-Jung
Park Hyun-Joo
Kang Tae-Sun
Ha Ji-Hye
Jeon Seol-Hee
Kim Young-Hoon
Kim Eun-Jung
Han Soon-Young
Kim Seung-Hee
Chung Myeon-Woo
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Abstract
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The safety pharmacology study was used as one of the methods that evaluate the safety of pharmaceuticals under development. After released by an international initiative such as International Conference on Harmonization (ICH) guideline (S7A), the study was universally applicable as common standard. And the KFDA has been acknowledged the safety pharmacology study data as safety evaluation of drugs. The safety pharmacology study proposed by ICH guideline includes core battery tests, follow up and supplemental studies. Core battery test of the safety pharmacology study is widely used in Korea, but follow up and supplemental studies have yet to be actively used. This is due in part to the fact that ICH guideline details on test criteria, type of tests and test methods. Indeed, it is difficult to develop new drugs without specific guidelines on follow up and supplemental studies. Therefore we made a draft guideline for follow up and supplemental studies for studying safety pharmacology study in order to support the new drug development by promoting the safety pharmacology study. This guideline includes many kinds of follow up and supplemental studies and detailed tests and it focuses on providing practical support for drug development. It is expected that this new guideline will take the level of safety pharmacology research in Korea to the next level.
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KEYWORD
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safety pharmacology, follow up and supplemental studies, guideline
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