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Hi Sam,
CV of Cmax in the pilot was lower than CV of AUCt.
This is almost never the true case. My guess is the pilot trial gave you the wrong impression of the product performance; the two products are not equivalent as evident by the last pivotal trial.
CV of Cmax in the pilot was lower than CV of AUCt.
This is almost never the true case. My guess is the pilot trial gave you the wrong impression of the product performance; the two products are not equivalent as evident by the last pivotal trial.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Regulatory Query for study repeat sam 2013-07-27 07:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Repeats ElMaestro 2013-07-27 11:01
- Repeats sam 2013-07-27 11:18
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 12:27
- Repeats sam 2013-07-27 12:45
- Bad science Helmut 2013-07-27 14:15
- Bad science sam 2013-07-28 09:05
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Posting style & incomplete information sam 2013-07-29 06:46
- RTFM! Helmut 2013-07-29 07:53
- RTFM! sam 2013-07-29 08:40
- copy & paste error or what? Helmut 2013-07-29 11:14
- copy & paste error or what? sam 2013-07-29 12:46
- copy & paste error or what? Helmut 2013-07-29 11:14
- Calm down! jag009 2013-07-29 16:06
- RTFM! sam 2013-07-29 08:40
- Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
- Futility rule? Helmut 2013-07-29 12:16
- Futility rule? ElMaestro 2013-07-29 12:46
- Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
- PE of AUC? Helmut 2013-07-29 12:45
- PE of AUC? sam 2013-07-29 12:56
- EOD Helmut 2013-07-29 13:18
- PE of AUC? sam 2013-07-29 12:56
- PE of AUC? Helmut 2013-07-29 12:45
- Futility rule? Helmut 2013-07-29 12:16
- Posting style & incomplete information jag009 2013-07-29 16:32
- Posting style & incomplete information sam 2013-07-30 06:08
- RTFM! Helmut 2013-07-29 07:53
- Posting style & incomplete information sam 2013-07-29 06:46
- Bad scienceElMaestro 2013-07-28 12:43
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Bad science sam 2013-07-28 09:05
- Repeats ElMaestro 2013-07-27 12:27
- Repeats jag009 2013-07-27 22:17
- Repeats ElMaestro 2013-07-27 23:11
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:18
- Regulatory Query for study repeat jag009 2013-07-27 22:29
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- More questions.. jag009 2013-07-30 16:53
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Repeats ElMaestro 2013-07-27 11:01
Ing. Helmut Schütz