tlag‽ [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-08-03 19:47 (2752 d 17:12 ago) – Posting: # 17660
Views: 9,202

Dear all,

In the product-specific guidance for Dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg we find:

Main pharmacokinetic variables:
Single dose: AUC0-t, AUCinf, Cmax (tlag and tmax)
90% confidence interval: 80.00–125.00% for AUC0-t, AUCinf, Cmax. Comparable median and range for tlag and tmax.


I beg your pardon, tlag
For delayed release products any change in tlag directly translates into a shifted tmax (see this presentation, slides 53–58). Whilst the latter PK metric is generally already covered by rich sampling (in order to “catch” Cmax) this is not the case for tlag. I don’t get it.

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
23,380 posts in 4,914 threads, 1,665 registered users;
93 visitors (0 registered, 93 guests [including 11 identified bots]).
Forum time: 12:00 CET (Europe/Vienna)

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

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