Bioequivalence and Bioavailability Forum

Multi-group studies ad nauseam [BE/BA News]

posted by Helmut  – Vienna, Austria, 2023-02-07 12:30 (616 d 17:34 ago) – Posting: # 23443
Views: 5,923

Hi Achievwin

❝ ❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

❝ Wishful thinking: I hope they give clear direction (kill once for all) - the annoying center/group effect portion for BE studies conducted in one country and in homogenous population.

Get prepared. Wanjie is a tough discussant.

❝ As many times and on many platforms they mentioned it is irrelevant in BE/ANDA contecxt …

The FDA? Where?

❝ … some academic curiosity folks keep brining this topic and keep the topic alive.

On the the contrary. Not a single publication; only problems with some regulators.
Expecting that groups could differ in their PK responses is beyond – not only my – intellectual reach. Can one reasonably assume that a study performed in the same CRO, same in-/exclusion criteria (→ similar demographics), quite often groups separated by only a couple of days, samples analyzed with the same bioanalytical method in the same lab, in a cross­over each subject acting as its own reference, have an effect on the response variable‽ Of course, not. IMHO, assuming the opposite is an insult to the mind.

»Λόγον ἔχεις;« »ἔχω.« »τί οὖν οὐ χρᾷ;«
‘Hast thou reason?’ ‘I have.’ ‘Why then makest thou not use of it?’
   — Marcus Aurelius (Meditations. Transl. by Meric Casaubon; 1634: Book 4. XI.)

Remember the FDA’s slogan back in the day?

In God we trust;
all others must bring data.
   — W. Edwards Deming

Easy. See this post.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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

Complete thread:

• New guidance on Sta­tis­tical Approaches to Establishing Bio­equi­va­lence Relaxation 2022-12-02 15:53 [BE/BA News] 
  • A first look Helmut 2022-12-02 16:43
    • A first look jag009 2022-12-02 17:58
      • A first look BRB 2022-12-02 18:20
    • SAS strikes back mittyri 2022-12-02 20:38
      • SAS strikes back Helmut 2022-12-02 22:30
        • Outliers? mittyri 2022-12-02 22:52
          • Outliers? Helmut 2022-12-02 23:11
        • SAS strikes back Achievwin 2023-02-07 07:23
    • model-based BE? mittyri 2022-12-07 16:26
      • model-based BE? Helmut 2022-12-10 10:13
        • Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
        • model-based BE? SMA 2023-01-17 09:41
    • A first look PharmCat 2022-12-21 19:30
    • A first look Rayhope 2023-01-06 06:56
  • Groups, sites… Helmut 2022-12-03 13:09
  • SxF ElMaestro 2022-12-04 06:34
    • SxF Helmut 2022-12-10 10:37
  • New guidance on Sta­tis­tical Approaches to Establishing Bio­equi­va­lence Mahmoud 2022-12-10 14:08
  • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
    • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
      • Multi-group studies ad nauseamHelmut 2023-02-07 11:30
        • Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
      • Webinar: Re­cord­ing avail­able Helmut 2023-04-01 10:38
    • Speed kills Helmut 2023-02-07 13:02