Subject-by-Formulation interaction? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2020-07-22 14:03 (1452 d 05:04 ago) – Posting: # 21775
Views: 2,679

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,099 posts in 4,857 threads, 1,647 registered users;
116 visitors (0 registered, 116 guests [including 10 identified bots]).
Forum time: 19:07 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

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