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RegisterTwo different batches of R: very bad idea [Study Assessment]
Dear cher0424,
I think it is much, much simpler than that. If you change the batch of the reference product in the middle of the study, regulators are very likely to reject the study whatever analyses you provide.
❝ So if change the batch of Reference, the regulator need sponsor to provide separate and total analysis for each period ?
I think it is much, much simpler than that. If you change the batch of the reference product in the middle of the study, regulators are very likely to reject the study whatever analyses you provide.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- BE study with two different batches of the reference product tarak_desai 2014-12-16 06:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study with two different batches of the reference product cher0424 2014-12-16 07:31
- BE study with two different batches of the reference product ElMaestro 2014-12-16 09:01
- BE study with two different batches of the reference product cher0424 2014-12-16 09:31
- Two different batches of R: bad idea Helmut 2014-12-16 13:36
- Two different batches of R: Analysis separately?? cher0424 2014-12-17 01:49
- Two different batches of R: very bad ideaOhlbe 2014-12-17 13:45
- Forget it! Helmut 2014-12-17 14:49
- Forget it! cher0424 2014-12-18 01:08
- Two different batches of R: Analysis separately?? cher0424 2014-12-17 01:49
- Two different batches of R: bad idea Helmut 2014-12-16 13:36
- BE study with two different batches of the reference product cher0424 2014-12-16 09:31
- BE study with two different batches of the reference product jag009 2014-12-16 15:24
- BE study with two different batches of the reference product felipeberlinski 2014-12-17 20:16
Ing. Helmut Schütz