The control of the consumer risk in the ames assay

Markus Neuhäuser & Ludwig A. Hothorn
Preclinical tests in genetic toxicology represent safety studies. Therefore, the primary concern in the evaluation of Ames test data is the control of the consumer risk, that is, the risk of erroneously concluding safety. Hence, an equivalence test procedure is adequate. This approach is presented beside the two-fold rule and classical tests for differences with respect to an order restricted alternative. © 1997, Drug Information Association. All rights reserved.
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