Lottery or science? [PK / PD]

posted by nobody – 2015-01-13 11:21 (3362 d 19:55 ago) – Posting: # 14275
Views: 9,217

Hi everybody!

Read this UK EPAR by chance, stopped on page 63, Table with CIs, including for Ctrough

click me to the EPAR

Nice example that one single concentration (maybe close to LLOQ) might mess up a whole BE-study and development program.

Is this still science or is it just some lottery (inviting for every kind of, ehhhmmm, data beautification)? This Ctrough parameter for multiple-dose studies is far from good, in my opinion... Apparently the replicate design was only chosen due to Ctrough, as Cmax showed moderate CVintra, and AUC even lower.


btw: page above:
"The elimination half life of quetiapine is approx. 7 hours. It can therefore be assumed that steady state would be reached..."

Really? Isn't it flip-flop kinetics for the PR-formulation and the IR half-life isn't interesting at all (except for absorption phase)? Just asking...


Edit: Category changed. [Helmut]

Kindest regards, nobody

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
98 visitors (1 registered, 97 guests [including 10 identified bots]).
Forum time: 07:17 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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