ticularly with low-dose chronic exposure. It is possible that existing data sets could be mined for pertinent information, particularly for common disorders or factors, such as diabetes, obesity, and alcohol consumption.

  • Additional data regarding intersubject variation in pharmacodynamic differences are needed across life stages and in various subpopulations before pharmacodynamic factors can be quantitated in risk assessment. Before such pharmacodynamic data can be generated, the critical targets and modes of action must be clarified from animal or in vitro studies.

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