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In-vitro studies
Mechanistic data might be supplemented by data from in-vitro studies, like as information on genotoxicity derived from reversion assays or other same assays. These studies should be conducted following GLP and other widely accepted protocols. Though, data from in-vitro studies should not be used as the sole source of information to predict the human risk.
- The results of in-vitro studies can enhance the understanding of mechanisms and phannacokinetics/dynamics. Though, such information may not be available in many cases and the risk assessment process should not be delayed pending development of mechanistic and pharmacokineticldynamic data.
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