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Hi Helmut!
What about
"In studies with more than two treatment arms (e.g. a three period study including two references, one from EU and another from USA, or a four period study including test and reference in fed and fasted states), the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question."
CPMP/QWP/EWP/1401/98 Rev. 1, page 14
May this eventually imply that in case of BE to the EU Reference but not to the USA Reference the study would pass?
IMHO this is one of the 'rationales' behind that crippled evaluation method that EU regulators are not interested in the BE result to the USA Reference.
❝ Close to nil ...
What about
"In studies with more than two treatment arms (e.g. a three period study including two references, one from EU and another from USA, or a four period study including test and reference in fed and fasted states), the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question."
CPMP/QWP/EWP/1401/98 Rev. 1, page 14
May this eventually imply that in case of BE to the EU Reference but not to the USA Reference the study would pass?
IMHO this is one of the 'rationales' behind that crippled evaluation method that EU regulators are not interested in the BE result to the USA Reference.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Curiosity: Running BE studies with more than 2 arms jag009 2012-06-11 15:01 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Common variance! Helmut 2012-06-11 16:23
- Common variance! jag009 2012-06-11 17:25
- Common variance! Helmut 2012-06-11 17:35
- Common variance! jag009 2012-06-11 20:03
- Common variance! ElMaestro 2012-06-11 20:34
- Common variance! Helmut 2012-06-12 01:03
- Common variance! ElMaestro 2012-06-12 13:22
- Common variance! Helmut 2012-06-12 01:03
- Common variance! ElMaestro 2012-06-11 20:34
- Common variance! jag009 2012-06-11 20:03
- Common variance! Helmut 2012-06-11 17:35
- Common variance! jag009 2012-06-12 19:56
- What if I run a study with 2 references? jag009 2012-06-12 20:00
- Common variance! Helmut 2012-06-12 20:39
- Two Referencesd_labes 2012-06-13 09:11
- Two References jag009 2012-09-10 22:48
- Two treatments only d_labes 2012-09-11 08:20
- Two References jag009 2012-09-10 22:48
- Two Referencesd_labes 2012-06-13 09:11
- Common variance! jag009 2012-06-13 16:08
- Common variance! jag009 2012-06-11 17:25
- Common variance! Helmut 2012-06-11 16:23
Ing. Helmut Schütz