Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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The Role of PK/PD Modeling and Simulation in Model-based New Drug Development

모델 기반학적 신약개발에서 약동/약력학 모델링 및 시뮬레이션의 역할

  • Yun, Hwi-Yeol (Drug Dissovery Lab.(pk), Cerrtral Research Institute, Choongwae Pharma Corporation) ;
  • Baek, In-Hwan (College of Pharmacy, Chungnam National University) ;
  • Seo, Jeong-Won (College of Pharmacy, Chungnam National University) ;
  • Bae, Kyung-Jin (College of Pharmacy, Catholic University of Daegu) ;
  • Lee, Mann-Hyung (College of Pharmacy, Catholic University of Daegu) ;
  • Kang, Won-Ku (College of Pharmacy, Catholic University of Daegu) ;
  • Kwon, Kwang-Il (College of Pharmacy, Chungnam National University)
  • 윤휘열 (중외제약 중앙연구소 신약연구실) ;
  • 백인환 (충남대학교 약학대학 임상약학 연구실) ;
  • 서정원 (충남대학교 약학대학 임상약학 연구실) ;
  • 배경진 (대구가톨릭대학교 약학대학) ;
  • 이만형 (대구가톨릭대학교 약학대학) ;
  • 강원구 (대구가톨릭대학교 약학대학) ;
  • 권광일 (충남대학교 약학대학 임상약학 연구실)
  • Published : 2008.12.31
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Abstract

In the recent, pharmacokinetic (PK)/pharmacodynamic (PD) modeling has appeared as a critical path tools in new drug development to optimize drug efficacy and safety. PK/PD modeling is the mathematical approaches of the relationships between 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 provides the information about systemic conditions for understanding the pharmacology and biology. These advantages of PK/PD model development are to provide the early decision-making information in new drug development process, and to improve the prediction power for the success of clinical trials. The purpose of this review article is to summarize the PK/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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