BE study inclusion & exclusion criteria [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2014-12-17 14:33 (4209 d 19:37 ago) – Posting: # 14091
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Dear Ohlbe,

❝ ❝ Tradition?


❝ Well, not only ! The amount of blood collected during a BE trial is of the same order of magnitude as the volume taken during a blood donation. In the interest of subject safety, most CROs just replicate the usual timelines between two blood donations.


Oh, you are right; THX for reminding me!

@cher0424: See also these old threads: #1297, #5244, #6180. I didn’t find a specific value in CDE’s BE-GL (2005). Is there a newer one?

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