Sex Differences in Drug Development

Blickpunkt der Mann 2008; 6 (1): 21-25

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– Determining sex differences in dosing, efficacy, and safety is an essential first step in personalizing treatment. – Sex differences are biologically based, arising from genetic, physiologic, and metabolic differences between men and women. – Drug development, a long and costly process, must evaluate the potential for sex differences in every step. – While not all drugs exhibit sex differences in pharmacokinetics or pharmacodynamics, examples of significant differences between men and women suggest that clinicians must always consider that possibility.