Subject-by-Formulation interaction? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2020-07-22 12:03 (19 d 02:08 ago) – Posting: # 21775
Views: 457

Hi Loky do,

» Now another case for a non highly variable drug, […]

What you confirmed already:What is still possible:
» Is it applicable to consider these subjects as outliers, is there any way to conclude this?

That’s similar to the cases we discussed before. Even if you would perform a statistical test (which is not acceptable acc. to current regulatory practice), you would get a p-value of 0.2453 which would speak against excluding them. Even for Health Canada (where an outlier assessment of studentized model residuals can be done if pre-specified in the protocol) you could exclude only one subject (≤5% if the sample size is ≥20).

» or could we re-dose them again to be confirmed?

Re-dosing is discouraged and likely not accepted.

» or simply the product fails :-|?

I’m afraid, yes.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,992 posts in 4,375 threads, 1,460 registered users;
online 25 (0 registered, 25 guests [including 12 identified bots]).
Forum time: Monday 14:11 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5