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RegisterEMEA Widening of acceptance limit [Regulatives / Guidelines]
Dear hiren379
IMHO you just have to point out in the protocol that the drug has no narrow therapeutic window and that a slightly higher variability of Cmax will not raise any safety concerns. This should be sufficient to allow the ethics committee to assess the study design and the planned evaluation of the results in order to give their approval.
Kind regards
Dan
IMHO you just have to point out in the protocol that the drug has no narrow therapeutic window and that a slightly higher variability of Cmax will not raise any safety concerns. This should be sufficient to allow the ethics committee to assess the study design and the planned evaluation of the results in order to give their approval.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- EMEA Widening of acceptance limit hiren379 2012-05-02 08:39 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMEA Widening of acceptance limitDr_Dan 2012-05-02 09:28
- EMEA Widening of acceptance limit hiren379 2012-05-10 10:37
- EMEA Widening of acceptance limit akinapally 2012-05-10 13:22
- EMEA Widening of acceptance limit mittyri 2015-02-03 13:16
- EMEA Widening of acceptance limit hiren379 2012-05-10 10:37
- EMEA Widening of acceptance limitDr_Dan 2012-05-02 09:28
Ing. Helmut Schütz