효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안

Title
효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안
Other Titles
Strategic Plans for the Implementation of Pharmacometric Methodology in Drug Regulatory Review Decisions
Author(s)
이상민[이상민]최보윤[최보윤]윤휘열[윤휘열]전다혜[전다혜]김명규[김명규]하지혜[하지혜]김영훈[김영훈]지은희[지은희]강원구한나영[한나영]신완균[신완균]오정미[오정미]
Keywords
Pharmacometrics; Pharmacokinetic-pharmacodynamic modeling; Simulation; Roadmap; Drug Review
Issue Date
201112
Publisher
한국임상약학회
Citation
한국임상약학회지, v.21, no.4, pp.339 - 346
Abstract
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.
URI
http://hdl.handle.net/YU.REPOSITORY/24018
ISSN
1226-6051
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약학대학 > 약학부 > Articles
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