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Beholder ★ Russia, 2015-03-29 18:52 (4110 d 09:15 ago) Posting: # 14629 Views: 5,712 |
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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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Helmut ★★★   Vienna, Austria, 2015-03-29 19:00 (4110 d 09:07 ago) @ Beholder Posting: # 14630 Views: 4,602 |
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Hi Beholder, Radio Yerevan answered: “In principle, yes. But only if you have a total of six ‘backups’ in the beginning with all the necessary paperwork signed.” — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr_Dan ★★ Germany, 2015-03-30 10:41 (4109 d 17:26 ago) @ Beholder Posting: # 14632 Views: 4,449 |
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Dear Beholder In order to answer your question you need to make up your mind how to randomize and how to allocate subjects to groups and treatment sequences. Once you have a plan (SOP) you can easily anser your question yourself. I hope this helps Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz