Log in
RegisterPre Treatment drug levels [Study Assessment]
Dear Helmut
Thank you for your swift reply
Unfortunately, maybe due to any cultural reason, it is difficult to get a positive return from some of the volunteers in these cases. But we are quite sure this was the case, since levels are almost 5% of the Cmax, which is compatible with taking a pill from 3 to 7 days earlier.
Anyway, as you said, lucky me to have no influence on the study outcome.
I'll have a look, hoping to provide you the correct links nowadays.
Many thanks,
Jaime
Thank you for your swift reply
❝
- Noncompliance of the subject with an exclusion criterion (=intake of the respective combination contraceptive)? Ask the subject again.
❝
- If the value was <5 % of Cmax, but reasonably close to the LLOQ, the result may be pure chance.
Unfortunately, maybe due to any cultural reason, it is difficult to get a positive return from some of the volunteers in these cases. But we are quite sure this was the case, since levels are almost 5% of the Cmax, which is compatible with taking a pill from 3 to 7 days earlier.
Anyway, as you said, lucky me to have no influence on the study outcome.
❝ ... To be honest I have given up to fix the many broken links in the Guidance page. Do you have a working URL?
I'll have a look, hoping to provide you the correct links nowadays.
Many thanks,
Jaime
Complete thread:
- Pre Treatment drug levels JOI 2011-11-16 11:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pre Treatment drug levels Helmut 2011-11-16 13:59
- Pre Treatment drug levelsJOI 2011-11-16 17:11
- Protocol Deviation Helmut 2011-11-16 18:11
- Pre Treatment drug levelsJOI 2011-11-16 17:11
- Pre Treatment drug levels Helmut 2011-11-16 13:59
Ing. Helmut Schütz