Log in
Register|
nobody nothing 2019-08-30 09:29 Posting: # 20530 Views: 536 |
|
|
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 |
Ing. Helmut Schütz