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nobody nothing 2019-08-30 11:29 (1699 d 03:34 ago) Posting: # 20530 Views: 2,002 |
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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