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Research Author: Staff Editor Last Updated: Jul 7, 2016 - 5:36:25 PM

FDA Is Committed to Determining Sex Differences in How Drugs Work

By Staff Editor
Feb 14, 2014 - 5:10:59 PM

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( - There's a lot happening these days with regard to the personalization of medicine and how drugs work differently in people, particularly in men versus women. FDA has a long history in understanding and analyzing these effects.

We've issued guidance to the pharmaceutical industry explaining in detail our expectations about analyzing clinical data for sex-related differences as well as differences according to other demographic groupings.  Those assessments, depending on the drug, may start with routine animal studies, in case a difference is evident by sex, but become most important when drugs begin to be tested in humans to see if data signal potential differences that require follow-up. 

Read the entire blog at FDA Voice.


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