Approved Pilot and Failed Pivotal Study [Study As­sess­ment]

posted by Tina – India, 2014-03-18 14:24 (4132 d 15:43 ago) – Posting: # 12654
Views: 18,131

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.

❝ 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:

UA Flag
Activity
 Admin contact
23,430 posts in 4,931 threads, 1,675 registered users;
61 visitors (0 registered, 61 guests [including 19 identified bots]).
Forum time: 07:07 CEST (Europe/Vienna)

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5