http://cliniqueresearchservices.com Revolutionizing Clinical Research in Africa Tue, 11 May 2010 21:22:25 +0000 en hourly 1 http://wordpress.org/?v=3.0 http://cliniqueresearchservices.com/2010/05/fda-on-race-and-ethnicity-data-in-clinical-trials/ http://cliniqueresearchservices.com/2010/05/fda-on-race-and-ethnicity-data-in-clinical-trials/#comments Mon, 10 May 2010 20:03:37 +0000 cgeorge http://cliniqueresearchservices.com/?p=321

The FDA guidance for Industry on Collection of Race and Ethnicity Data in Clinical Trials states “differences in response to medical products have already been observed in racially and ethnically distinct subgroups of the U.S. population… For example, in the United States, Whites are more likely than persons of Asian and African heritage to have abnormally low levels of an important enzyme (CYP2D6) that metabolizes drugs belonging to a variety of therapeutic areas, such as antidepressants, antipsychotic, and beta blockers”.

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