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This guidance highlights selection of a minimal anticipated biological effect level, as this is becoming increasingly important as more targeted therapies are being developed that are very specific and potent with predicted pharmacologically active doses well below a dose that is thought to be safe based on the NOAEL.11 Table 2

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As these scientific questions are progressively answered, accumulating preclinical evidence provides a rationale to explore therapeutic strategies targeting macrophage metabolism as potential future avenues for the clinical management of SRMI