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KMID : 0941820110210040339
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Korean Journal of Clinical Pharmacy
2011 Volume.21 No. 4 p.339 ~ p.346
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Strategic Plans for the Implementation of Pharmacometric Methodology in Drug Regulatory Review Decisions
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Lee Sang-Min
Choi Bo-Yoon
Yun Hwi-Yeol
Jun Da-Hae
Kim Myung-Gou
Ha Ji-hye
Kim Young-Hoon
Ji Eun-Hee
Kang Won-Ku
Han Na-Young
Shin Wan-Gyoon
Oh Jung-Mi
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Abstract
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Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.
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KEYWORD
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Pharmacometrics, Pharmacokinetic-pharmacodynamic modeling, Simulation, Roadmap, Drug Review
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