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RegisterSubject did not swallow the tablets [Study Assessment]
Dear All,
We found out from sample analysis that there was no detection of drug in the plasma samples for one subject for both phases. During drug administration, this subject was observed to have swallowed the tablets.
Can we consider this as outlier ?? Non-compliance ??
What is the right way to present the case ?
Is it right to confront the subject ? The subject argues that he swallowed. Nevertheless, the results of sample analysis will never lie.
Highly appreciate your comments and suggestion.
Thank you.
Regards,
Ken
Edit: Category changed. [Helmut]
We found out from sample analysis that there was no detection of drug in the plasma samples for one subject for both phases. During drug administration, this subject was observed to have swallowed the tablets.
Can we consider this as outlier ?? Non-compliance ??
What is the right way to present the case ?
Is it right to confront the subject ? The subject argues that he swallowed. Nevertheless, the results of sample analysis will never lie.
Highly appreciate your comments and suggestion.
Thank you.
Regards,
Ken
Edit: Category changed. [Helmut]
Complete thread:
- Subject did not swallow the tabletsKen 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 tablets Dr_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
Ing. Helmut Schütz