Bioequivalence and Bioavailability Forum • Preliminary simulations

Preliminary simulations [BE/BA News]

posted by Helmut – Vienna, Austria, 2022-05-01 17:56 (722 d 22:36 ago) – Posting: # 22947
Views: 4,490

Hi ElMaestro,

❝ your post is potentially highly significant.

Potentially!

❝ ❝ Is this really the intention? The wider the range in t_max, the more easily products will pass.

❝

❝ The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?

Right, I don’t get it. I’m afraid, this is one joins the ‘methods’ of the PKWP made up out of thin air.

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone. Stephen Senn. Statistics in Drug Development. Wiley; 2004. p. 386.

‘Common sense’ is not always a good idea. The obvious is most often wrong.

It’s complicated. Like yesterday but this time no shift.

[image]

That’s what I expect.

❝ I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.

That’s wishful thinking taking the review process into account. Deadline for comments July 31^st.

❝ […] I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).

Yep. ƒ₂ is not a statistic (depends on the number of samples and intervals). Given that, no closed form to estimate the location, its CI, power (and hence, the Type I Error) exists because the distribution is unknown. That’s similar to the situation we are facing here.

PS: Du hast Mehl in deiner Mehlkiste.

—
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:

EMA: New product-specific guidances Helmut 2022-04-08 15:17
- How would you implement it? ElMaestro 2022-04-09 11:45
  - Confuse a Cat Inc. Helmut 2022-04-09 18:40
    - Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
      - Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
        
        Confuse a Cat Inc. Helmut 2022-04-11 13:59
        
        Range Ohlbe 2022-04-11 15:48
        
        Range Helmut 2022-04-11 16:07
        
        Range Ohlbe 2022-04-11 16:20
        
        Range Helmut 2022-07-28 14:43
      - So many questions, so few answers Helmut 2022-04-11 13:03
      - Preliminary simulations Helmut 2022-04-30 14:59
        
        Preliminary simulations ElMaestro 2022-04-30 19:10
        
        Preliminary simulationsHelmut 2022-05-01 15:56
        Revisions of the PSGLs final Helmut 2023-06-23 13:29
        
        Revisions of the PSGLs final dshah 2023-06-28 14:43
        
        EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
        New simulations & some desultory thoughts Helmut 2023-06-29 11:34
        
        SCNR. A heretic alternative. Helmut 2023-06-30 11:50
      - Simulated distributions Helmut 2022-05-02 13:43