Article
Initial consideration for use of transgenic mutation assays in a regulatory submission.
Environmental and molecular mutagenesis - 1 Jan 1996
Sofuni T, Suzuki T, Hayashi M
Abstract excerpt
As an initial consideration for use of TM assays in a regulatory submission, we focus here especially on the following questions: (1) What conditions would trigger the performance of a TM assay? (2) What data set is sufficient to support a negative result? and (3) What increase in mutation frequency is considered to be a positive result? In the first question, we discuss outcomes from traditional tests such as...
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