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RegisterBE 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?
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?
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Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- BE in hepatic impairment?nobody 2019-08-30 09:29
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