• The Korean Journal of Applied Statistics
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• v.33 no.2
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• pp.137-145
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• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• 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.

• 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.35 no.2
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• pp.251-263
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• 2022

Phase I clinical trial is called 'Dose finding study'. It is first step of experimenting on humans with new drugs developed through animal experiments or vitro experiments. The important area of interest in designing Phase I clinical trial is determining the dose that acceptable level to the patients and provides the greatest efficacy. In this paper, we explain about methods to determine the maximum tolerated dose using various stopping rules. The SM3, NM, Rim, J3, BSM methods are compared through simulation. And we consider how the methods might be reformed. As a result of the simulation, BSM estimated the MTD closest to the target toxicity probability. J3 method required the least number of subjects. These results are due to the feature of the stopping rules of both methods. The BSM adds 2 or 1 subject at the same dose level when there is a toxic reaction. In addition, the J3 method has a smaller number of subjects than the other methods. If the methods are improved by combining these features, MTD can be estimated more efficiently. If the total number of subjects can be reduced while using the stopping rule of the BSM, accurate estimation is possible for a small number of subjects.

• 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.

• Journal of the Daesoon Academy of Sciences
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• v.37
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• pp.53-105
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• 2021

The purpose of this study is to clarify the meaning of Gwonji (權智, Authority and Foreknowledge) through the phrases contained in the section, Gwonji of the Jeon-gyeong (known in English as The Canonical Scripture), and to compare the changes that each verse from Gwonji underwent by juxtaposing it against the sixth edition of Daesoon Jeong-gyeong (which was published prior to the Jeon-gyeong) to explore the term's literary meaning. In order to save the world, Sangje descended to human world and performed the Cheonjigongsa (Reordering Works of the Universe) for nine years with the power he exercises over the Three Realms of Heaven, Earth, and Humanity. Based on the plan set by the Cheonjigongsa, Sangje's teachings were spread to humanity and provided as the basis for building the earthly paradise. From this perspective, this study demonstrates its significance by providing a comprehensive approach to the Jeon-gyeong by highlighting the subject of Sangje's authority and wisdom as recorded in the section titled Gwonji. There is also value in the variant verses from Gwonji that the study discovered by comparing and analyzing the phrases from chapters one and two of Gwonji as they appear in the Jeon-gyeong with their equivalents from the sixth edition of Daesoon Jeong-gyeong, which was published in 1965, nearly a decade before Daesoon Jinrihoe's publication of the Jeon-gyeong in 1974. The results of this comparative study of parallel passages related to Gwonji are as follows: First, Gwonji can be understood as the authority and wisdom of Sangje, and this is the core element in realizing the Earthly Paradise through His Cheonjigongsa. Second, phrases related to Sangje's authority and wisdom are spread out in the seven sections of the Jeon-gyeong, and they were written to emphasize the main purpose suggested in each section or chapter. Third, in sections other than Gwonji, the great power of Sangje is exercised to treat matters related to deities and social problems, whereas in Gwonji part, it is dedicated to the performance of Cheonjigongsa. Fourth, there are five sections of the Jeon-gyeong which are organized into chapters. All of these sections and their chapters indicate the year when key events transpired. Fifth, when passages from chapter one of Gwonji is compared to parallel passages from Daesoon Jeon-gyeong, there are several verses that vary in terms of their wording and also sentences that indicate a different dates or times for certain events.