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RegisterEMEA Widening of acceptance limit [Regulatives / Guidelines]
Hello friends,
EMEA states below
"Those HVDP for which a wider difference in Cmax is considered clinically irrelevant based on a sound clinical justification can be assessed with a widened acceptance range."
Is it necessary to give the justification a priori in the protocol for no relevance of wider difference in Cmax.
EMEA states below
"Those HVDP for which a wider difference in Cmax is considered clinically irrelevant based on a sound clinical justification can be assessed with a widened acceptance range."
Is it necessary to give the justification a priori in the protocol for no relevance of wider difference in Cmax.
Complete thread:
- EMEA Widening of acceptance limithiren379 2012-05-02 08:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMEA Widening of acceptance limit Dr_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 limit Dr_Dan 2012-05-02 09:28
Ing. Helmut Schütz