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

posted by ElMaestro  – Denmark, 2019-10-07 00:45 (1716 d 17:58 ago) – Posting: # 20671
Views: 5,823

Hi Hötzi,

❝ 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?

Am thinking loud here: You can bootstrap a principal answer to such questions as well.
You generate a dissolution dataset with n chambers for T and R; then you resample with replacement to generate datasets with m chambers (m > n, presumably) per product, to find out at which level of m you get an f2 limit >50.

This is quite simple, actually, to do the programming and simulation. But yes, if you end up with 326 chambers per product then I guess you are royally screwed.

We could do a publication about this. We'd need a candidate dataset, I don't think I have one for this which I could put into the public domain.

Could this even be done as a two-stage approach? You first look at bootstrap f2 levels in the initial n-chamber scenario. If you are passing, stop. Else, find your sample size m and run the (m-n) chambers on top, then re-bootstrap the whole thing. This would be a "two-treatment, m-chamber, tripple bootstrap, two-stage dissolution trial", and you may need to work with increased coverage intervals for alpha preservation.

Man, I should win a Nobel prize for this idea.:-D

Pass or fail!

Complete thread:

UA Flag
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
125 visitors (0 registered, 125 guests [including 11 identified bots]).
Forum time: 18:43 CEST (Europe/Vienna)

You should treat as many patients as possible with the new drugs
while they still have the power to heal.    Armand Trousseau

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz