BE study inclusion & exclusion criteria [Design Issues]

posted by Ohlbe – France, 2014-12-16 18:29 (4207 d 20:46 ago) – Posting: # 14087
Views: 16,441

Dear cher0424 and Helmut,

❝ ❝ and why donation of blood (one unit or 350 mL) within 90 days prior to study check-in in exclusion criteria


❝ 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.

Regards
Ohlbe

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