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

posted by nobody – 2019-02-14 16:01 (2337 d 04:13 ago) – Posting: # 19921
Views: 5,742

❝ ❝ ❝ 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:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,691 registered users;
56 visitors (0 registered, 56 guests [including 9 identified bots]).
Forum time: 21:15 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere.    Marilyn Monroe

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