’Some’ should read the GL (and again, and again) [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-07-27 13:48 (430 d 08:01 ago) – Posting: # 20451
Views: 3,460

Hi Datacollector,

» […] 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 …

OK, then the agency should trigger an inspection1 rather than just ‘suspect’ sumfink. Again: Statistics2 cannot help. BTW, it is yet another – all too common – misconception that the p-value gives the prob­ability that the Null-hypothesis is true.

» … but is not prepared to say so in black and white.

Well, they are happy to speculate in black and white. As I wrote before, only a failure in randomization can be assessed in an inspection. Everything else: No way.

» Have you encountered this kind of response?

Yes. By the German BfArM three days (‼) ago. :thumb down:

Potential serious risk to public health not already raised by the RMS as major objection.
However, regarding ████, serious concerns on the results from BE-study ████ remain.

  1. Though I don’t see a clear reason in “Guidance on triggers for inspections of bioequivalence trials: Quick scan”.
  2. Even raising the question is some kind of double moral standards. We are not allowed to exclude anything based on statistics alone (not even reanalyse a sample). Quod licet Iovi, non licet bovi?

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,086 posts in 4,398 threads, 1,468 registered users;
online 8 (0 registered, 8 guests [including 2 identified bots]).
Forum time: Tuesday 21:49 CEST (Europe/Vienna)

To know the history of science is to recognize the mortality
of any claim to universal truth.    Evelyn Fox Keller

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