LOWER DOSES MIGHT INCLUDE ONE HALF AND ONE QUARTER OF THE MTD MUCH CONTROVERSY

Lower doses might include one half and one quarter of

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LOWER DOSES MIGHT INCLUDE ONE- HALF AND ONE-QUARTER OF THE MTD MUCH CONTROVERSY ABOUT BASIS FOR SELECTION OF DOSES TO BE TESTED STUDY PARAMETERS INVESTIGATED INCLUDE EXTENSIVE HISTOPATHOLGY CANCER BIOASSAY Generally, are control group and three Tx groups per sex High dose group should approximate MTD* MTD* = Highest Practical Dose which can be administered experimentally without affecting overall survival N.B.: Dose Selection is NOT intended to approximate anticipated human exposure level. #50 #50 #50 #50-100 HIGH (4x) MEDIUM (2x) LOW (x) CONTROL Approximate Number of Animals Required for 95% Confidence Interval Equal to Size of the Effect (Spontaneous Background Rate = 0.01) 40 +/-.10 .10 .01 .11 ED 10 1,100 +/-.01 .01 .01 .02 ED 1 80,000 +/-.001 .001 .01 .011 ED.001 Approximate sample size (each) (C.I.) 95% Excess Prop. of Animals with tumors control Treated Case
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