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Mode of Action and Adverse Outcome Pathway), which do not necessarily need new animal studies, should be considered ( 3.2 Example demonstrating how NAMs can be used to inform regulatory decision making In the decision summary of a PMTA, the CTP Technical Project Lead (TPL) stated Results from the in vitro toxicology studies demonstrated that combusted cigarette smoke fractions (total particulate matter (TPM), gas vapor phase (GVP), or both) were mutagenic, cytotoxic, and genotoxic

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