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RegisterRegulatory Query for study repeat [Study Assessment]
Dear John,
Not possible to provide the numbers
There was no change in the formulation or process.
I have checked the Pilot and Pivotal data thoroughly.
The study populations are totally different. Pilot are carried out in other CRO and Pivotal in other
No.
Best Regards
Sam
Edit: Standard quotes restored. [Helmut]
❝ 1. Similar to what the other gurus have asked, please provide the numbers to us.
Not possible to provide the numbers
❝ 2. Was there a change in the formulation or process? From pilot batch to scale-up batch... Please check because I have seen a few cases from my previous company (and friend's companies) that the issue was related to the manufacturing process. I work closely with formulators these days (small company) and you will be surprised to hear the things that they educate me on...
There was no change in the formulation or process.
❝ 3. Have you checked the PK data in details, both pilot and pivotal. Look for outliers? Don't bother with the post-hoc power business.
I have checked the Pilot and Pivotal data thoroughly.
❝ 4. Any difference in study population between studies?
The study populations are totally different. Pilot are carried out in other CRO and Pivotal in other
❝ 5. Drug has complicated kinetics?
No.
Best Regards
Sam
Edit: Standard quotes restored. [Helmut]
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 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 repeatsam 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 repeatsam 2013-07-29 12:36
- Repeats ElMaestro 2013-07-27 11:01
Ing. Helmut Schütz