nobody
nothing

2019-08-30 09:29

Posting: # 20530
Views: 536
 

 BE in hepatic impairment? [BE/BA News]

Hello again!

Today I have to read this here:

https://www.fdanews.com/articles/192544-persion-petitions-fda-to-raise-the-safety-bar-for-extended-release-opioid

But the originator found differences in PK in mild/moderate hepatic impairment not worth any dose adjustment according to the current label and the differences as outlined in the FDA AssRep are unimpressive. I'm trying to figure out a formulation-related influence of hepatic function on BA/BE...

Lawyers looking for some work? How low can you go? Is that state-of-the-art in 2019?

Kindest regards, nobody
Activity
 Admin contact
20,343 posts in 4,272 threads, 1,401 registered users;
online 5 (2 registered, 3 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 03:52 CET

That which is static and repetitive is boring.
That which is dynamic and random is confusing.
In between lies art.    John Locke

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