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

posted by nobody – 2019-02-14 16:01 (1922 d 13:51 ago) – Posting: # 19921
Views: 4,467

❝ ❝ ❝ 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

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