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RegisterApproved Pilot and Failed Pivotal Study - same test? [Study Assessment]
Hello Dr Dan!
I myself have the same doubts, but that's what they tell us, that the same batch was used in both studies. It's the same batch number.
The in vitro studies must be conducted before the in vivo study as far as I know.
It seems to me that they have done exactly that.
My position to the sponsor is to run the pilot having all the data necessary for submission, but due to internal procedures they can't always do that by motives not known by me.
❝ It is hard to believe especially for Drug B that the only thing that changed from pilot to pivotal was the sample size...
I myself have the same doubts, but that's what they tell us, that the same batch was used in both studies. It's the same batch number.
❝ You state that the sponsor could not submit the pilot studies to the regulator because not all the in vitro studies required were performed. [...](o.k. the data would have been collected after the conduct of the BE study but they would still demonstrate the quality of the test formulation).
The in vitro studies must be conducted before the in vivo study as far as I know.
❝ Differences in production between the lab scale batch and the validation batches led to a slightly different formulation and consequently to different study results. I am looking forward to your reply.
It seems to me that they have done exactly that.
My position to the sponsor is to run the pilot having all the data necessary for submission, but due to internal procedures they can't always do that by motives not known by me.
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study kumarnaidu 2014-03-18 05:03
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study - same test? Dr_Dan 2014-03-18 11:30
- Approved Pilot and Failed Pivotal Study - same test?Lucas 2014-03-18 13:38
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 10:28
- Approved Pilot and Failed Pivotal Study Ohlbe 2014-03-18 11:15
- Approved Pilot and Failed Pivotal Study Helmut 2014-03-18 13:06
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 15:55
- Approved Pilot and Failed Pivotal Study luvblooms 2014-03-19 05:16
- Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 07:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
Ing. Helmut Schütz