Communications for Statistical Applications and Methods

  • 제18권2호
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  • Pages.179-187
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  • 2011
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  • 2287-7843(pISSN)
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  • 2383-4757(eISSN)
한국통계학회 (The Korean Statistical Society)
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제1상 임상시험에서 곡선적합을 이용한 MTD 추정법

Maximum Tolerated Dose Estimate by Curve Fitting in Phase I Clinical Trial

  • 허은하 (가톨릭대학교 의학통계학과) ;
  • 김동재 (가톨릭대학교 의학통계학과)
  • Heo, Eun-Ha (Department of Biostatistics, The Catholic University of Korea) ;
  • Kim, Dong-Jae (Department of Biostatistics, The Catholic University of Korea)
  • 투고 : 20100900
  • 심사 : 20111100
  • 발행 : 2011.03.31
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초록

제 1상 입상시험의 주된 목적은 신약의 최대허용용량(Maximum tolerated dose; MTD)의 추정이다. 본 논문에서는 실험으로 얻어진 Dose-toxicity data를 S자 모형에 적합 시켜 MTD를 추정하는 방법을 제안하였다. 멈춤 규칙(stopping rule)에 의해 MTD가 결정되는 방법과 미리 정해진 표본수에서 실험을 종료하고 MTD를 추정하는 기존의 추정방법을 본 논문에서 제안한 방법과 모의실험을 통하여 비교하였다.

The purpose of a Phase I clinical trial is to estimate the maximum tolerated dose, MTD, of a new drug. In this paper, the MTD estimation method is suggested by curve fitting the dose-toxicity data to an S-shaped curve. The suggested MTD estimation method is compared with established MTD estimation procedures using a Monte Carlo simulation study.

키워드

참고문헌

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