• Communications for Statistical Applications and Methods
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• v.19 no.6
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• pp.877-884
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• 2012

Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

• Journal of Korean Society for Quality Management
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• v.39 no.2
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• pp.329-336
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• 2011

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.

• Communications for Statistical Applications and Methods
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• v.19 no.1
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• pp.57-64
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• 2012

Phase I clinical trials determine the maximum tolerated dose(MTD) of a new drug. In this paper, we proposed a two-stage MTD estimation method by a Stopping rule in a phase I clinical trial. The suggested MTD estimation method is compared to the standard design(SM3) and the continual reassessment method(CRM) using a Monte Carlo simulation study.

• Communications for Statistical Applications and Methods
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• v.18 no.2
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• pp.179-187
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• 2011

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.

• The Korean Journal of Applied Statistics
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• v.27 no.1
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• pp.13-20
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• 2014

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

• Korean Journal of Applied Biomechanics
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• v.32 no.1
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• pp.24-30
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• 2022

Objective: The purpose of this study was to determine the factors of successful and unsuccessful movements through the analysis of kinematics and muscle activity of the Free Aerial Cartwheel on the balance beam. Method: Subjects (Age: 22.8 ± 2.4 yrs., Height: 158.7 ± 5.0 cm, Body mass: 54.1 ± 6.4 kg, Career: 13 ± 2.4 yrs.) who were currently active as female gymnasts participated in the study. They had no history of surgical treatment within 3 months. Subject criteria included more than 10 years of professional experience in college and professional level of gymnastics and the ability to conduct the Free Aerial Cartwheel on the Balance Beam. Each subject performed 10 times of Free Aerial Cartwheel on the balance beam. One successful trial and one unsuccessful trial (failure) among 10 trials were selected for the comparison. Results: It was found that longer time required in case of unsuccessful trial when performing the Free Aerial Cartwheel on the balance beam compared with successful trial. It is expected to be the result of movement in the last landing section (i.e. phase 5). In addition, it was found that the center of gravity of the body descends at a high speed to perform the jump (i.e. phase 2) in order to obtain a sufficient jumping height when the movement is successful while the knee joint is rapidly extended to perform a jump when movement fails. In the single landing section after the jump (i.e. phase 4), if the ankle joint rapidly dorsiflexed after take-off and the hip joint rapidly flexed, so landing was not successful. Conversely, in a successful landing movement, muscle activity of the biceps femoris was greatly activated resulting no shaking in the last landing section (i.e. phase 5). Conclusion: In order to succeed in this movement, it is necessary to perform a strong jump after rapidly descending the center of gravity of the body using the force of the biceps femoris muscle. Further improvement of the skills on the balance beam requires the analysis of the game-like situation with continuous research on kinematic and kinematic analysis of various techniques, jumps, turns, etc.

• Communications for Statistical Applications and Methods
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• v.6 no.2
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• pp.543-564
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• 1999

The principal aim of a sequential phase I clinical trial in which the toxicity reponses of a group of patient(s) determine the dose level of the next patient(s) group is to estimate the maximal tolerated dose(MTD) of a new drug, In this paper we compared with a simulation study the performance of the MTD estimates that are determined by a stopping rule in a design and also those that are determined by analyzing the data after a clinical trial is terminated. To the latter belong the mean median mode and maximum likelihood estimates. For the Standard Methods the stopping rule MTD is quite inefficient but the median MTD has a best efficiency and is robust with respect to the three different toxicity curves. The problem of non-convergence of MLE MTD is severe. A more improved MTD estimate is produced by combining the advantages of the various MTD estimates and its efficiency is better than the single median MTD estimate especially for the toxicity curve of an unlucky choice of dose levels. The simulation results suggest that simple types of phase I designs can be combined with relatively standard analytic techniques to provide a more efficient MTD estimate.

• Journal of the Korean Data and Information Science Society
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• v.23 no.6
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• pp.1085-1091
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• 2012

Phase I clinical trials are designed to identify an appropriate dose; the maximum tolerated dose, which assures safety of a new drug by evaluating the toxicity at each dose-level. The adjusted maximum tolerated dose estimation is presented by stopping rule in phase I clinical trial on this research. The suggested maximum tolerated dose estimation is compared to the standard method3 and NM method using a Monte Carlo simulation study.

• The Korean Journal of Applied Statistics
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• v.32 no.5
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• pp.741-752
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• 2019

The purpose of a Phase I Clinical Trial is to determine the maximum tolerated dose (MTD). MTD is important because it affects subsequent clinical trials; however, the existing method has a problem due to an inadequate dose allocated to patients. In this paper, an MTD estimation method is proposed to complement the problems of the existing MTD estimation method. The suggested method applies the initial acceleration step to the modified continual reassessment method. Monte Carlo Simulation Study is adapted to compare a suggested MTD estimation method with the standard design and the modified continual reassessment method.

• 대한임상약리학회:학술대회논문집
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• 1995.06a
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• pp.17-19
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• 1995