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RegisterEthics? [Regulatives / Guidelines]
Hi Friends,
I want to update the status for my previous question.
As an internal regulator of the firm, the approach doesn't sound good even for me...
But have to do... (proceeded for analysis of first group) and the test product is found to be bioequivalent (sponsor's luck)
The same was submitted to the agency. No RTR (refuse to receive) received and no bio query yet (again sponsor's luck).
Regards,
Bharathi
Edit: THX for the update! [Helmut]
I want to update the status for my previous question.
As an internal regulator of the firm, the approach doesn't sound good even for me...
But have to do... (proceeded for analysis of first group) and the test product is found to be bioequivalent (sponsor's luck)
The same was submitted to the agency. No RTR (refuse to receive) received and no bio query yet (again sponsor's luck).
Regards,
Bharathi
Edit: THX for the update! [Helmut]
Complete thread:
- Extent of Protocol deviation accepted by the Agency bharathi 2014-09-16 12:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ethics? Helmut 2014-09-16 13:07
- Ethics?bharathi 2015-10-01 06:57
- Ethics? Helmut 2014-09-16 13:07
Ing. Helmut Schütz