Log in
RegisterValue with no confimation [Regulatives / Guidelines]
Dear All,
Recently in one of the study, we have encountered a problem where the concentration could not be confirmed for one time-point, and the concentration is reported as value without confirmation in a situation where sample could not be repeated due to the unavailability of the plasma sample. Now the question is for PK and statistical analysis what concentration should be considered?
Should we consider the concentration with no confirmation or reported as missing and perform the PK and statistical analysis or by both methods?
Your valuable comments on this will be highly appreciated
Thanking you in advance for reply.
Best Regards,
Ratnakar
Recently in one of the study, we have encountered a problem where the concentration could not be confirmed for one time-point, and the concentration is reported as value without confirmation in a situation where sample could not be repeated due to the unavailability of the plasma sample. Now the question is for PK and statistical analysis what concentration should be considered?
Should we consider the concentration with no confirmation or reported as missing and perform the PK and statistical analysis or by both methods?
Your valuable comments on this will be highly appreciated
Thanking you in advance for reply.
Best Regards,
Ratnakar
Complete thread:
- Value with no confimationratnakar1811 2011-04-07 13:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Value with no confimation Ohlbe 2011-04-07 13:44
- Value with no confimation ratnakar1811 2011-04-08 06:25
- Value with no confimation Dr_Dan 2011-04-08 09:10
- Value with no confimation paulhurleyuk 2011-04-08 10:51
- Value with no confimation ratnakar1811 2011-04-08 06:25
- Value with no confimation Ohlbe 2011-04-07 13:44
Ing. Helmut Schütz