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KMID : 0941820080180020084
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Korean Journal of Clinical Pharmacy
2008 Volume.18 No. 2 p.84 ~ p.96
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The Role of PK/PD Modeling and Simulation in Model-based New Drug Development
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Yun Hwi-Yeol
Baek In-Hwan
Seo Jeong-Won
Bae Kyung-Jin
Lee Mann-Hyung
Kang Won-Ku
Kwon Kwang-II
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Abstract
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In the recent, pharmacokinetic(PK)/pharmacodynamic(PD) modeling has appeared as a critical path tools in new drugdevelopment to optimize drug efficacy and safety. PK/PD modeling is the mathematical approaches of the relationshipsbetween PK and PD. This approach in new drug development can be estimated inaccessible PK and PD parameters,evaluated competing hypothesis, and predicted the response under new conditions. Additionally, PK/PD modeling pro-vides the information about systemic conditions for understanding the pharmacology and biology. These advantages ofPK/PD model development are to provide the early decision-making information in new drug development process, andto improve the prediction power for the success of clinical trials. The purpose of this review article is to summarize thePK/PD modeling process, and to provide the theoretical and practical information about widely used PK/PD models.This review also provides model schemes and the differential equations for the development of PK/PD model.
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KEYWORD
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Pharmacokinetic(PK)/Pharmacodynamic(PD) modeling, new drug development process.
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