Approved Pilot and Failed Pivotal Study [Study Assessment]
No no no I am not suggesting to submit pilot passed without the pivotal. I was saying that the company could submit the entire information to the regulatory body for the regualtors to advise.
I wouldnt have thought of a pivotal if the pilot study had passed. It would have been up to justifying in the clinical overview of the bioequivalence established with the pilot and the associated non-requirement of pivotal study with completion of all other required invitro-studies
Kind regards,
Tina
❝ Though regulators advise us for taking innovator from different batches, we know the pain of establishing BE if variability change for a different batch of the innovator. The regulators arent keen on suing the reference innovator until and unless it comes to light. May be you could share the entire data with the regulatory body and discuss on the BE and non-BE with different batch and have the regulators give a solution to it.
I wouldnt have thought of a pivotal if the pilot study had passed. It would have been up to justifying in the clinical overview of the bioequivalence established with the pilot and the associated non-requirement of pivotal study with completion of all other required invitro-studies
Kind regards,
Tina
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
- 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 StudyTina 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 StudyTina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02