TREE-TYPE ALGORITHM FOR STATISTICAL ANALYSIS IN CHRONIC TOXICITY STUDIES

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概要

• 論文の詳細を見る

• An appropriate statistical methodology in toxicity studies has been discussed over the last two decades and many statistical methods have already been proposed. Many practical problems, however, still remain unresolved and most pharmaceutical industries have been using a tree-type algorithm routinely to analyze repeated-dose toxicity study data. In considering routine use of statistical analysis in toxicological studies, standardization of statistical methodology is necessary and the decision tree has an important role. In this article, the problems, relating to tree-type algorithms are summarized. Then we propose a new tree-type algorithm, which targets quantitative data in repeated-dose studies in rodents, usually sample size per group between 10 to 20, based on the following two important principles:"using a parametric method "and "suitable for intuition of toxicologists". An example of its application to actual toxicity study data is demonstrated. The performance of this new method is also evaluated using historical data. However, it should be noted that the intention of this paper is not to make a definite solution of the decision tree. Several other alternatives can be considered. Since there is no single theoretically correct solution of tree-type algorithms, too formal a use of the decision tree is not recommended. We must not forget the exploratory nature of evaluating repeated toxicity data.

• 日本トキシコロジー学会の論文
• 1998-08-17

著者

• YOSHIMURA Isao

  Faculty of Engineering, Tokyo University of Science

• Nomura Mamoru

  イナリサーチ

• Nakamura Miho

  Drug Safety Research Laoboratory Daiichi Pharmaceutical Co. Ltd.

• Nomura Mamoru

  Drug Safety Research Laboratory Daiichi Pharmaceutical Co. Ltd.

• Nomura M

  Clinical Pathology Working Group The Japan Pharmaceutical Manufacturers Association

• Nomura Mamoru

  Drug Safety Research Laboratory Dai-ichi Pharmaceutical Co.ltd.

• Hamada Chikuma

  Department Of Pharmacoepidemiology Faculty Of Medicine University Of Tokyo

• Hamada Chikuma

  Department Of Management Of Science Faculty Of Engineering Tokyo University Of Science

• Hamada Chikuma

  Biomedical Statistics Course Graduate School Of Engineering Tokyo University Of Science

• Yoshimura Isao

  Tokyo Univ. Sci. Tokyo Jpn

• Yoshimura I

  Faculty Of Engineering Science University Of Tokyo

• Yoshimura Isao

  Faculty Of Engineering Kansai University

• Nomura Mamoru

  Drug Safety Research Center Daiichi Pharmaceutical Co. Ltd.

• Matsumoto K

  Drug Safety Research Laboratories Pharmaceutical Research Division Takeda Chemical Industries Ltd.:l

• YOSHINO Kei

  Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.

• MATSUMOTO Kazuhiko

  Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.

• Yoshino Kei

  Toxicology Research Laboratories Central Pharmaceutical Research Institute Japan Tobacco Inc.

• Yoshimura I

  Graduate School Of Engineering Tokyo University Of Science

• Nakamura Miho

  Drug Safety Research Center Developmental Research Laboratories Daiichi Pharmaceutical Co. Ltd.

• Nomura Mamoru

  Japan Pharmaceutical Manufactures Association (jpma):daiichi Pharmaceuticals Co.ltd

• Nomura Mamoru

  Drug Safety Research Cehter Developmental Research Lab. Daiichi Pharmaceutical Co. Ltd.

• Yoshimura Isao

  Faculty Of Eng. Kansai Univ.

• Matsumoto Kazuhiko

  Toxicology Research Laboratories Central Pharmaceutical Research Institute Japan Tobacco Inc.

• Matsumoto Kazuhiko

  Toxicological Research Laboratories Toyo Jozo Co. Ltd.

• Hamada Chikuma

  Department of Pharmacoepidemiology, Faculty of Medicine, University of Tokyo

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