STATISTICAL EVALUATION OF UMBRELLA DOSE-RESPONSE RELATIONSHIPS(Categorical Data Analysis)
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概要
- 論文の詳細を見る
In the drug development process, it is essential to assess the relationship (mechanism) between dose and response of a biological system following drug administration. This mechanism is known as the "dose-response relationship". Then, dose-response relationships are often evaluated based on a monotonic hypothesis. However, in practice, we may often encounter non-monotonic dose-response relationships, such as the umbrella relationship, which then makes interpretation of the relationships somewhat problematic. In this paper, to assess such umbrella dose-response relationships, the cumulative dose logit model is proposed and applied to an example. To evaluate properties of this model, some Monte-Carlo studies are performed. The results of the cumulative dose logit model are compared with those of the quadratic logit model. This indicates that the cumulative dose logit model provides more stable estimates than the quadratic logit model in estimating the maximum effective dose. It is suggested that the cumulative dose logit model is appropriate for assessing non-monotonic dose-response relationships.
- 日本計算機統計学会の論文
著者
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SAKAMOTO Wataru
Department of Applied Chemistry, Graduate School of Engineering, Nagoya University
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Fujisawa Masaki
Clinical Control Group Research Development Division Grelan Pharmaceutical Co. Ltd.
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Goto Masashi
Department Of General Medicine And Clinical Epidemiology Kyoto University Graduate School Of Medicin
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Baba Mitsumasa
Biostatistics
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Baba Mitsumasa
Biostatistics : Data Management Dept. Medical Dept. Global Development Japan Pharmacia K. K.
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Goto Masashi
Department Of Informatics And Mathematical Science Graduate School Of Engineering Sciences Osaka Uni
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Goto Masashi
Department Of Comprehensive Care And Education Tenri Hospital
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Sakamoto Wataru
Department Of Informatics And Mathematical Science Graduate School Of Engineering Sciences Osaka Uni
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Goto Masashi
Department of Applied Chemistry, Faculty of Engineering, Nagoya University
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