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Dear Helmut,
Thanks for your time.
The heading of the Tables are correct as i have not given the Table for Fed pilot in my previous post but yes ratios of all the three parameters were same as per the pivotal study.
Fed Pilot Study Results (Total Sample szie 18):
Fed Pivotal Study Results (Total Sample szie 48):
Fasting Pilot study Data (Total Sample szie 18):
Fasting Pivotal Study results (Total Sample szie 64)
I have personally monitored the whole study but there were no observation at that time.
Now the final sample size on which data has been evaluated are given in each tables.
Hope i have given all the information required by you, if not pl let me know so that i can add more if required.
Once again thanks for time and valuable responses.
So pl let me know if i need revisit the CRO and do the Audit. Also suggest me for the main areas where i need to concentrate during the audit so that the root cause of the study failure can be find out and i can prepare the justification for repeating the study.
Regards
Sam
Thanks for your time.
The heading of the Tables are correct as i have not given the Table for Fed pilot in my previous post but yes ratios of all the three parameters were same as per the pivotal study.
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 14Fed 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 44Fasting Pilot study Data (Total Sample szie 18):
Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%) n
Ln(AUCINF_obs) 87.02 69.00 109.75 0.48 37.07 14
Ln(AUClast) 95.22 77.65 116.76 0.56 32.34 14
Ln(Cmax) 89.43 77.16 103.66 0.81 23.13 14Fasting Pivotal Study results (Total Sample szie 64)
Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%) n
Ln(AUCINF_obs) 98.26 93.05 103.77 100.0 18.0 61
Ln(AUClast) 98.14 92.84 103.74 100.0 18.3 61
Ln(Cmax) 79.10 74.09 84.45 100.0 21.9 61I have personally monitored the whole study but there were no observation at that time.
Now the final sample size on which data has been evaluated are given in each tables.
Hope i have given all the information required by you, if not pl let me know so that i can add more if required.
Once again thanks for time and valuable responses.
So pl let me know if i need revisit the CRO and do the Audit. Also suggest me for the main areas where i need to concentrate during the audit so that the root cause of the study failure can be find out and i can prepare the justification for repeating the study.
Regards
Sam
Complete thread:
- Regulatory Query for study repeat sam 2013-07-27 07:50 [Study Assessment]
![[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 informationsam 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 informationsam 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