Backups [Design Issues]

posted by Beholder  – Russia, 2015-03-29 18:52 (4101 d 14:03 ago) – Posting: # 14629
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Hello!

If we imagine that there is BE study and it is conducted in 3 groups due to impossibility to dose all subjects in one day. There are 2 backups for each group which are not dosed but can replace the volunteer before dosing.

Would it be possible to use such approach regarding the backups, namely, to use these two backups for first group as volunteers in second group in case these 2 backups did not entered active phase of the BE study (i.e. were not used as the backups and were not dosed)?

THX in advance.

Best regards
Beholder

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