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

posted by Datacollector – United Kingdom, 2019-07-27 13:34 (633 d 23:45 ago) – Posting: # 20450
Views: 4,080

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:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Wednesday 13:19 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

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