Confuse a Cat Inc. [BE/BA News]

posted by ElMaestro  – Denmark, 2022-04-09 23:47 (769 d 08:54 ago) – Posting: # 22921
Views: 5,389

Hi Hötzi,

should we submit a dataset to EMA and suggest them to publish it along with a description (numerical example) of how exactly they wish to derive the decision?

When FDA indicated that they were going in the direction of in vitro popBE for inhalanda and nasal sprays they published a dataset and showed exactly how to process the data to figure out the pass / fail criterion that satisfies the regulator. If EMA would do the same here we'd have all doubt eliminated.
I think we need to know exactly:
1. Do we use nonparametrics or not?
2. Do we use logs or not?
3. Is the decision of 20% comparability based on a confidence interval or on something else?
3a. If there is a CI involved, is it a 90% or 95% CI or something else?
4. Are we primarily working on ratio or on a difference?
5. Is the bootstrap involved?
6. How should we treat datasets from parallel trials, and how should we treat data from XO (i.e. how to handle considerations of paired and non-paired options)?

My gut feeling is that they want nonparametrics for the Tmax comparability part (yes I am aware of the sentence).

Actually, perhaps they just want the decision taken on basis of the estimates of medians and ranges from min to max?

If we submit a dataset, let us make sure we submit one with ties (the one I pasted above had none).

Pass or fail!

Complete thread:

UA Flag
 Admin contact
23,029 posts in 4,834 threads, 1,641 registered users;
42 visitors (0 registered, 42 guests [including 10 identified bots]).
Forum time: 08:42 CEST (Europe/Vienna)

The most erroneous stories are those we think we know best–
and therefore never scrutinize or question.    Stephen Jay Gould

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