Bioequivalence and Bioavailability Forum

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

posted by Helmut  – Vienna, Austria, 2019-07-27 13:48  – Posting: # 20451
Views: 1,041

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.

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?

—
Cheers,
Helmut Schütz


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

Complete thread:

• Good News, Bad News Datacollector 2019-07-27 12:09 [Study As­sess­ment] 
  • Good News only Helmut 2019-07-27 13:15
    • Good News only, but not according to some Datacollector 2019-07-27 13:34
      • ’Some’ should read the GL (and again, and again) Helmut 2019-07-27 13:48
      • Good News only, but not according to some ElMaestro 2019-07-27 13:50
        • My stuff Helmut 2019-07-27 16:55
          • My stuff ElMaestro 2019-07-27 17:38
            • My stuff Datacollector 2019-07-27 19:13
              • ≡ Helmut 2019-07-27 23:53
                • Sequence effect Vs Subject effect? mittyri 2019-07-28 15:19
                  • Sequence effect Vs Subject effect? Helmut 2019-07-28 15:59
                    • Sequence effect Vs Subject effect? mittyri 2019-07-28 16:20
                      • Oops! Helmut 2019-07-28 16:36