Missing samples [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2019-10-17 10:22 (414 d 14:20 ago) – Posting: # 20700
Views: 5,735

Hi ElMaestro,

» This, I think, relates originally to FDA's data driven policies. A subject can walkout on her/his own initiative without even stating a reason, that's how GCP works. There is no clause saying she/he can't come back.
» I know, this is messy, but that's the way it is in some clinics.

I see. Since the data are useless for the FDA’s reference-scaling maybe this was a trick-shot of the CRO to milk the sponsor.

» The alternative may be worse, depending on how you look at it: If a subject misses an ambulatory pk-sample […] should she/he then be considered completely out?

I like your examples! That’s an area of improvement which requires a good amount of intellectual horsepower. Not easy but the idea is to come up with rules specifying how many missings (and where) in the profile will likely lead to unreliable estimates of a given PK metric.

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
21,240 posts in 4,431 threads, 1,482 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Friday 23:42 CET (Europe/Vienna)

Normality is a myth; there never was, and never will be,
a normal distribution.    Roy C. Geary

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