Preclinical safety pharmacology controls

Translated into statistics, this implies that for safety pharmacology the risk of Type 2 errors (false negatives) should be decreased as much as possible, even if there is an increase in the risk of Type 1 errors (false positives). In other words, the statistical tests employed in safety pharmacology should err in the direction of oversensitivity rather than the reverse. A test substance found not to have significant safety risks based on preclinical studies, even after the use of oversensitive statistics, is more likely to be truly devoid of risk. As a consequence, the statistical analyses proposed for the CNS safety procedures described below (mainly two-by-two comparisons with control using Student s t tests) have been selected for maximal sensitivity to possible effects per dose at the acknowledged risk of making more Type 1 errors. 

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