Early ADME-Tox Test Strategy

Knowledge Based Decision Making

Results of Early ADME-Tox Test Package:

e.g., MN in vitro, HPRT, Cytotox, CA, Comet Assay

"A number of developments, including the construction of genetically engineered cell lines expressing specific activating enzymes, may provide the potential for endogenous activation. The choise of the cell lines used should be scientifically justified (e.g. by the relevant of the cytochrome P450 isoenzymes for the metabolism of the test substance)."

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