Gender differences adverse events

Analysis of the database for age-related differences of efficacy, adverse events, dose and (gender) relationships. A geriatric database may contain data from the main phase II and III studies or from a geriatric-specific study. 

What do we mean by a reasonable number Reasonable is that number which would be expected to show a significant gender clinical difference if a real difference is present, and probably will only apply to efficacy and adverse events 5% or larger, because a difference in low-incidence adverse events will not show up until the drug is in the market. This would mean at least 300 women exposed to the new drug. The number of patients should be based on what is judged to be a clinically... 

Frackiewicz EJ, Sramek JJ, Cutler NR. Gender differences in depression and antidepressant pharmacokinetics and adverse events. Ann Pharma-cother 2000 34 80-88. 

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