Dabigatran EMA - product-specific guide [Regulatives / Guidelines]

posted by nobody – 2019-02-14 14:01  – Posting: # 19921
Views: 596

» » » Aren’t you notoriously shouting “It’s the originator, stupid…”?
» » Could you elaborate on this. No clue what this might mean.
»
» See there.

yeah, but you need irony tags in here,don'T you?

» » If you want a duel, choose your weapon
» » :hungry:
»
» Surströmming?

No chemical weapons.

» » » I’m more concerned about the first footnote in the guidance […]. Was the EMA’s PKWP not aware of the the FDA’s guidance?
» »
» » Narrow therapeutic range... maybe in the USA. In the EU there are no mass tort trials...
»
» I don’t like the idea that someone widens the limits for this stuff.

...maybe we will never see such generics in our lifetime. Wait and see...

Kindest regards, nobody

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,404 posts in 4,122 threads, 1,323 registered users;
online 13 (1 registered, 12 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 17:11 UTC

No rational argument will have a rational effect on a man
who does not want to adopt a rational attitude.    Karl R. Popper

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5