Research on the method of data analysis for drug development

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The method of the ED_<50> estimation for 7 altenative assays including Nuclear Red mthod, Cristal Violet method, Colony Formation method was studied. A non-linear least squares method applied on the raw data using a logistic dose-response curve was realized to be useful. Two computor programs based on SAS and C-language was obtained. The programs were applied on the data in a validation study organized by the Society of Alternative Test for Animal Experiments, yielding valuable information.An effective predictor for in vivo Draize eye scores based on some alternative assays was obtained by applying a variable selection method with the criterion of PRESS or its approximately equivalent criterion of doubly adjusted multiple correlation coefficient.Statistical issues on the use of historical controls were investigated and remarks related them were arranged in a report.