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Journal of Korean Society for Quality Management 2011;39(2): 329-. |
| 약물독성시험에서 실험설계가 MTD의 결정에 미치는 영향 |
| 이윤동1, 이은경2 |
1서강대학교 경영학부
2이화여자대학교 통계학부 |
| Effect of the Erimental Design on the Determination of MTD in Phase I Clinical Trial |
| Yoon-Dong Lee1, Eun-Kyung Lee2 |
1Department of Business Administration, Sogang University
2Department of Statistics, Ewha Womans University |
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| ABSTRACT |
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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. |
| Key Words:
Clinical Trial Design;Phase I Trial;Adaptive Design;TER; |
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