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RegisterRegulatory Query for study repeat [Study Assessment]
Dear Sir,
Recently we have carried two pilot studies (Fasting and Fed) for a molecule and based on the pilot study data we have calculated the sample size and time point for the Pivotal study. Fortunately the data for the Fed study ratio is totally replica of the Pilot Fed study and our Fed study data qualify the BE criteria of 80-125% with 100 % power. But unfortunately our fasting study ratio unexpectedly lower than the Pilot Fasting study and the study does qualify the 80-125% and the power 100%. So based on the above fact we cannot file the molecule for regulatory approval. Since the Fasting pivotal data has unexpected outcome. So we wanted to repeat the whole study in other CRO from the beginning because of the unexpected ratio in the Pivotal study. In that case kindly suggest if there will be any regulatory hurdles if we repeat the whole study in other CRO or regulatory will easily accept the data of the second study if it qualifies the BE criteria.
Hope for your positive reply.
Regards
Sam
Edit: Category changed. [Helmut]
Recently we have carried two pilot studies (Fasting and Fed) for a molecule and based on the pilot study data we have calculated the sample size and time point for the Pivotal study. Fortunately the data for the Fed study ratio is totally replica of the Pilot Fed study and our Fed study data qualify the BE criteria of 80-125% with 100 % power. But unfortunately our fasting study ratio unexpectedly lower than the Pilot Fasting study and the study does qualify the 80-125% and the power 100%. So based on the above fact we cannot file the molecule for regulatory approval. Since the Fasting pivotal data has unexpected outcome. So we wanted to repeat the whole study in other CRO from the beginning because of the unexpected ratio in the Pivotal study. In that case kindly suggest if there will be any regulatory hurdles if we repeat the whole study in other CRO or regulatory will easily accept the data of the second study if it qualifies the BE criteria.
Hope for your positive reply.
Regards
Sam
Edit: Category changed. [Helmut]
Complete thread:
- Regulatory Query for study repeatsam 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 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 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