Bioequivalence and Bioavailability Forum • Ahem

Ahem – number of units? [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2019-10-06 18:14 (958 d 14:59 ago) – Posting: # 20670
Views: 4,032

Hi ElMaestro,

» » […] Bootstrapping is preferred over ƒ₂ even if the validity criteria are met?
»
» I think yours is the right interpretation.

Was also the opinion of some experts at BioBridges. Left the audience speechless.

» And it is free of cost, right? [etc. etc.]

Sure. The problem is the ‘regulatory crep’ I suspected in my post. Jiři showed nice simulations about the false positive rate. To squeeze the lower CL ≥50 is not another league but another sport. How many units will we have to test in the future? 24, 48, 96?

—
Dif-tor heh smusma 🖖
Helmut Schütz

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

Complete thread:

EMA: Mahalanobis distance is dead... Helmut 2018-11-09 18:01 [Dissolution / BCS / IVIVC]
- EMA: Mahalanobis distance is dead... ElMaestro 2018-11-09 19:12
  - Is ƒ2 dead as well – always bootstrapping? Helmut 2019-10-06 15:27
    - Is ƒ2 dead as well – always bootstrapping? ElMaestro 2019-10-06 17:54
      - Ahem – number of units?Helmut 2019-10-06 18:14
        
        Ahem – number of units? ElMaestro 2019-10-06 22:45
        
        Ahem – number of units? wienui 2019-10-07 19:11
        Ahem – number of units? elba.romero 2021-10-28 00:08
        
        Ahem – number of units - ICH M9 Relaxation 2021-10-28 16:20