Bioequivalence and Bioavailability Forum

Webinar: Recording available [BE/BA News]

posted by Helmut – Vienna, Austria, 2023-04-01 12:38 (61 d 21:37 ago) – Posting: # 23520
Views: 714

Hi Achievwin & all,

❝ 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.

❝ ❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Yesterday the recording was posted. You need some stamina watching it. Presenters essentially read out what’s on their slides and didn’t provide any background information whatsoever. Since the slides were available for download before, I prepared two comments/questions. Tried to make them short and as concise as possible.

To Donald Schuirmann:
If s_wR <0.294 and hence, ABE has to be assessed, the model is overparameterized in a partial replicate design. Therefore the software’s optimizer might fail to converge. I suggest to use FA0(1) instead of FA0(2) in SAS lingo.
To Wanjie Sun:
In a meta-study (300 studies, same sites) we found – as expected – a significant Treatment-by-Group (p <0.1) in appr. 10% of studies, i.e., at the false positive rate. If a true T×G is simulated (GMRs of groups 20% apart), it is correctly detected in 47% of cases but not in the 53% others. IMHO, testing for T×G is futile as is any attempt to ‘explain or interpret’ it.
To Zhen Zhang:
What is the agency’s definition of an outlier?

None of my questions were selected. After I posted the second, I received a message “Please post your question only once.” Heck, it was a different one. One which was selected:

How is a highly variable drug defined and is this information available on and within the RLD labeling?

Oh dear, what a waste of time!

—
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 nauseam Helmut 2023-02-07 11:30
      - Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
    - Webinar: Recording availableHelmut 2023-04-01 10:38
  - Speed kills Helmut 2023-02-07 13:02

Webinar: Re­cord­ing avail­able [BE/BA News]

Complete thread:

Webinar: Recording available [BE/BA News]