품질경영학회지 (Journal of Korean Society for Quality Management)

  • 제39권2호
  • /
  • Pages.329-336
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  • 2011
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  • 1229-1889(pISSN)
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  • 2287-9005(eISSN)
한국품질경영학회 (Korean Society for Quality Management)
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약물독성시험에서 실험설계가 MTD의 결정에 미치는 영향

Effect of the Erimental Design on the Determination of MTD in Phase I Clinical Trial

  • 투고 : 2011.05.13
  • 심사 : 2011.06.15
  • 발행 : 2011.06.30
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초록

The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.

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참고문헌

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