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Dear All,
We have to carry out pivotal study for which we have validated method in which internal standard used was not deteurated or labeled molecule, but now we are planning to go for deuterated IS and again re-validate the method before subject analysis therefore I would like to know whether this change in IS for pivotal study is acceptable to the regulatory.
Regards,
Ketan
We have to carry out pivotal study for which we have validated method in which internal standard used was not deteurated or labeled molecule, but now we are planning to go for deuterated IS and again re-validate the method before subject analysis therefore I would like to know whether this change in IS for pivotal study is acceptable to the regulatory.
Regards,
Ketan
Complete thread:
- Change in ISketan 2012-10-12 08:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Change in IS Ohlbe 2012-10-12 10:06
Ing. Helmut Schütz