I wouldn’t do that [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2014-02-06 03:35 (3703 d 13:54 ago) – Posting: # 12352
Views: 9,008

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
[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
22,957 posts in 4,819 threads, 1,638 registered users;
102 visitors (0 registered, 102 guests [including 7 identified bots]).
Forum time: 17:29 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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