Good News only, but not according to some [Study As­sess­ment]

posted by Datacollector – United Kingdom, 2019-07-27 15:34 (1732 d 08:28 ago) – Posting: # 20450
Views: 5,883

Hi Helmut,
Thanks for your kind and considered response.
To answer your question on the origin of the concerns-
I was not at first unduly concerned- the study was submitted. However, a well regarded EU regulatory agency has raised objections on public health grounds. Treatment by period interaction has been mentioned. I can't see how that could arise given that the design of the study is fine and assuming there was no major issue in the conduct of the study. I can only infer that the agency suspects that the study has not been executed correctly but is not prepared to say so in black and white. Have you encountered this kind of response?

Thanks & Regards

Complete thread:

UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,655 registered users;
62 visitors (0 registered, 62 guests [including 7 identified bots]).
Forum time: 00:02 CEST (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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