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Nonparmetric Method for Identifying Effective and Safe Doses using Placement

유효하고 안전한 용량 결정에 위치를 이용한 비모수적 방법

  • Kim, Sunhye (Department of Biomedicine.health science, The Catholic University of Korea) ;
  • Kim, Dongjae (Department of Biomedicine.health science, The Catholic University of Korea)
  • 김선혜 (가톨릭대학교 의생명.건강과학과) ;
  • 김동재 (가톨릭대학교 의생명.건강과학과)
  • Received : 2014.10.01
  • Accepted : 2014.11.10
  • Published : 2014.12.31

Abstract

Typical clinical dose development studies consist of the comparison of several doses of a drug with a placebo. The primary interest is to find therapeutic window that satisfying both efficacy and safety. In this paper, we propose nonparametric method for identifying effective and safe doses in linear placement using score function. The Monte Carlo simulation is adapted to estimate the power and the family-wise error rate(FWE) of proposed procedure are compared with previous methods.

일반적으로 약제 용량 결정 연구는 대조군과 여러 용량 수준을 비교하여 유효성과 안전성을 동시에 만족하는 약물의 치료 범위(therapeutic window)를 찾아내는 데에 관심이 있다. 이 논문에서는 안전성과 유효성을 동시에 만족하는 용량 결정을 위하여 선형 위치(linear placement)에 점수함수(score function)를 이용한 비모수적 검정법을 제안하였다. 또한 Monte Carlo 모의실험을 통하여 기존의 모수적 방법들과 검정력(power)과 FWE(family-wise error rate)를 비교하였다.

Keywords

References

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