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

posted by nobody – 2019-02-14 16:01 (1887 d 22:01 ago) – Posting: # 19921
Views: 4,337

❝ ❝ ❝ 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
22,984 posts in 4,822 threads, 1,650 registered users;
56 visitors (0 registered, 56 guests [including 5 identified bots]).
Forum time: 15:03 CEST (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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