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RegisterPosting style & incomplete information [Study Assessment]
Hi,
This really bugs me (even though I am looking at fed data). You have a 15% increase in AUCt ratio between pilot and pivotal.
Question 1) I am sure that you did. But did you use the same lot# of the reference product throughout the program (yes, all pilot and pivotal studies)?
John
❝ Fed Pilot Study Results (Total Sample szie 18):
❝ Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%) n
❝ Ln(AUCINF_obs) 87.39 69.74 108.72 51.0 32.2 14
❝ Ln(AUClast) 81.09 67.57 97.32 65.0 26.3 14
❝ Ln(Cmax) 87.07 67.52 113.11 41.0 37.8 14
❝
❝ Fed Pivotal Study Results (Total Sample szie 48):
❝ Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%) n
❝ Ln(AUCINF_obs) 96.45 91.53 101.64 100.0 14.5 44
❝ Ln(AUClast) 95.94 90.95 101.21 100.0 14.8 44
❝ Ln(Cmax) 87.91 81.81 94.47 99.99 20.3 44
This really bugs me (even though I am looking at fed data). You have a 15% increase in AUCt ratio between pilot and pivotal.
Question 1) I am sure that you did. But did you use the same lot# of the reference product throughout the program (yes, all pilot and pivotal studies)?
John
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 informationjag009 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 science ElMaestro 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