median Tmax [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2019-10-17 06:42 (463 d 22:27 ago) – Posting: # 20699
Views: 2,282

Hi mittyri,

» […] use the published median Tmax?

Yep – should be given in the SmPC/label. The exclusion should be done by the PI (or a sub-investigator). Sometimes I find statements like “the decision will be done by the pharmacokineticist after discussion with the sponsor” in protocols. Fishy.

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
21,310 posts in 4,445 threads, 1,489 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Saturday 05:10 UTC (Europe/Vienna)

Any sufficiently advanced technology
is indistinguishable from magic.    Arthur C. Clarke

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