Log in
RegisterISR of an unstable drug [Bioanalytics]
Dear Ohlbe,
As per EMA's BMV Sec 6: "It is therefore recommended to evaluate accuracy of incurred samples by reanalysis of study samples in separate runs at different days". So doesn't this mean that they have to be run in seperate batches and the ISR be performed on diffrent day?
I have come across a regulatory inspector who insisted that repeats samples be run in separate batches. In a study we had only a single repeat and since there was only a single repeat in the entire study we analyzed this repeat along with last batch of subject samples. This was properly named indicating that this was a repeat.
The inspector insisted that even though there was a single repeat in the entire study this cannot be clubbed with subject samples although properly named and has to be repeated in a separate batch. So can be extrapolated to ISR samples also?
Regards
P.S.Srinivas
As per EMA's BMV Sec 6: "It is therefore recommended to evaluate accuracy of incurred samples by reanalysis of study samples in separate runs at different days". So doesn't this mean that they have to be run in seperate batches and the ISR be performed on diffrent day?
I have come across a regulatory inspector who insisted that repeats samples be run in separate batches. In a study we had only a single repeat and since there was only a single repeat in the entire study we analyzed this repeat along with last batch of subject samples. This was properly named indicating that this was a repeat.
The inspector insisted that even though there was a single repeat in the entire study this cannot be clubbed with subject samples although properly named and has to be repeated in a separate batch. So can be extrapolated to ISR samples also?
Regards
P.S.Srinivas
Complete thread:
- ISR of an unstable drug wxp 2013-10-17 15:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ISR of an unstable drug sarada06884 2013-10-18 07:49
- ISR of an unstable drug wxp 2013-10-18 09:02
- ISR of an unstable drug Ohlbe 2013-10-18 14:39
- ISR of an unstable drug wxp 2013-10-21 04:15
- ISR of an unstable drugsarada06884 2013-10-21 11:55
- ISR of an unstable drug Ohlbe 2013-10-21 12:01
- ISR of an unstable drug sarada06884 2013-10-18 07:49
Ing. Helmut Schütz