Bioequivalence and Bioavailability Forum

Webinar: Recording available [BE/BA News]

posted by Helmut – Vienna, Austria, 2023-04-01 12:38 (384 d 09:04 ago) – Posting: # 23520
Views: 2,840

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❝ ❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence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. 🥱 😴
The 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 comments/questions and tried to make them short and as concise as possible.

↗️ Donald Schuirmann
- If \(\small{s_\text{wR}<0.294}\) 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.
↗️ Wanjie Sun
- In a meta-study (N ~ 330) we found – as expected – a significant (p <0.05) Group-by-Treatment in ≈5% of studies, i.e., at the false positive rate. If a true G×T is simulated (GMRs 20% apart), it is correctly detected in 34% of cases but not in the 66% others. IMHO, testing for G×T is futile as is any attempt to ‘explain or interpret’ it.
↗️ Zhen Zhang
- What is the agency’s definition of an outlier?

Interestingly, none of my questions were selected by the moderator. 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]