I wouldn’t do that [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2014-02-06 03:35 (3333 d 20:12 ago) – Posting: # 12352
Views: 8,509

Hi Mittyri,

❝ Could you explain your practice and guideline interpretation:

I don’t base my decisions primarily on guidelines. ;-) You never know why a subject drops out. What if vomiting was drug-related or even a SUSAR? The sponsor has the budget to analyse all samples, so do it – as far as they are available. Some background:
PS: EMA’s GL is ambiguous: “Drop-out and withdrawal of subjects should be fully documented. If available, concentration data and pharmacokinetic parameters from such subjects should be presented in the individual listings, but should not be included in the summary statistics.”
I would say: Make them available.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
22,550 posts in 4,724 threads, 1,606 registered users;
14 visitors (0 registered, 14 guests [including 6 identified bots]).
Forum time: 23:47 CET (Europe/Vienna)

That which is static and repetitive is boring.
That which is dynamic and random is confusing.
In between lies art.    John Locke

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