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RegisterMethod not sensitive enough [Study Assessment]
Hi Helmut and colleagues
thanks for your replies and interactions,
my concern is the study is already submitted by the sponsor to the H.A, and the study results are known, also the samples are out of studied long term stability, can we just exclude the results of the affected subjects from the statistics?
and plz to confirm that every individual subject should fulfil the less than 5% of Cmax criteria for the future?
thanks again very much for your inteaction, its highly appreciated.
thanks for your replies and interactions,
my concern is the study is already submitted by the sponsor to the H.A, and the study results are known, also the samples are out of studied long term stability, can we just exclude the results of the affected subjects from the statistics?
and plz to confirm that every individual subject should fulfil the less than 5% of Cmax criteria for the future?
thanks again very much for your inteaction, its highly appreciated.
Complete thread:
- BEQ inquiry from health authority Aymanmy 2019-12-18 08:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BEQ inquiry from health authority Dr_Dan 2019-12-18 14:46
- Method not sensitive enough Helmut 2019-12-18 15:16
- Revalidation? mittyri 2019-12-18 16:52
- Revalidation? Helmut 2019-12-18 17:40
- Method not sensitive enoughAymanmy 2019-12-18 17:58
- Method not sensitive enough Helmut 2019-12-18 18:54
- Method not sensitive enough Aymanmy 2019-12-19 08:21
- Method not sensitive enough Helmut 2019-12-18 18:54
- Revalidation? mittyri 2019-12-18 16:52
Ing. Helmut Schütz