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RegisterTest samples expired for FED study [Regulatives / Guidelines]
Hi
Right, this is exactly what is also done in phase III trials. But if you use another Test batch you can simply explain this in the clinical overview module 2.5 of the dossier.
❝ Retest, extend the shelf life if within specs, release for CT?
Right, this is exactly what is also done in phase III trials. But if you use another Test batch you can simply explain this in the clinical overview module 2.5 of the dossier.
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Test samples expired for FED study taiyab.jameel 2020-03-05 10:02 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Test samples expired for FED study jag009 2020-03-05 21:57
- Test samples expired for FED study taiyab.jameel 2020-03-06 04:15
- Different batches Helmut 2020-03-06 11:21
- Different batches taiyab.jameel 2020-03-06 12:26
- Different batches Marcelo Davanco 2020-03-06 12:37
- Different batches wienui 2020-03-07 16:10
- The soft-spoken voice of reason Helmut 2020-03-07 22:04
- Different batches Marcelo Davanco 2020-03-08 00:32
- Different batches wienui 2020-03-08 10:19
- Different batches wienui 2020-03-07 16:10
- Different batches Marcelo Davanco 2020-03-06 12:37
- Different batches taiyab.jameel 2020-03-06 12:26
- Different batches Helmut 2020-03-06 11:21
- Test samples expired for FED study taiyab.jameel 2020-03-06 04:15
- Test samples expired for FED study ElMaestro 2020-03-05 22:27
- Test samples expired for FED studyDr_Dan 2020-03-11 11:39
- Test samples expired for FED study jag009 2020-03-05 21:57
Ing. Helmut Schütz