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RegisterSubject did not swallow the tablets [Study Assessment]
Dear Ken
If the subject swallowed the study medication or not can not be proven. You asked the subject but still have doubts. This is exact what you have to present in the study report. However, since the subject showed no plasma concentration in both phases there is no influence on the study result and consequently you do not have to exclude this subject as an outlier from statistical evaluation. The comparison of test and reference remains unaffected. Nevertheless you could present in paragraph 13 of the study report (discussion) mean values for AUC and Cmax with and without the subject under discussion.
I hope this helps.
Kind regards
Dr_Dan
If the subject swallowed the study medication or not can not be proven. You asked the subject but still have doubts. This is exact what you have to present in the study report. However, since the subject showed no plasma concentration in both phases there is no influence on the study result and consequently you do not have to exclude this subject as an outlier from statistical evaluation. The comparison of test and reference remains unaffected. Nevertheless you could present in paragraph 13 of the study report (discussion) mean values for AUC and Cmax with and without the subject under discussion.
I hope this helps.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Subject did not swallow the tablets Ken Peh 2014-06-20 05:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject did not swallow the tablets ElMaestro 2014-06-20 08:01
- Subject did not swallow the tabletsDr_Dan 2014-06-20 10:08
- Subject did not swallow the tablets Ken Peh 2014-06-20 15:33
- Subject did not swallow the tablets ElMaestro 2014-06-20 15:45
- Subject did not swallow the tablets Ken Peh 2014-06-23 08:45
- Subject did not swallow the tablets ElMaestro 2014-06-20 15:45
- Subject did not swallow the tablets Ken Peh 2014-06-20 15:33
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