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

posted by Helmut Homepage – Vienna, Austria, 2019-02-14 14:52 (1868 d 23:26 ago) – Posting: # 19920
Views: 4,279

Hi nobody,

❝ ❝ Aren’t you notoriously shouting “It’s the originator, stupid…”?

❝ Could you elaborate on this. No clue what this might mean.


See there.

❝ If you want a duel, choose your weapon

:hungry:


Surströmming?

❝ ❝ 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.

❝ What buys you the widening for Cmax, when both parameters are highly variable? :confused:


Business as usual in all jurisdictions following the EMA’s strange approoach (i.e., WHO; ASEAN States, Australia, Brazil, Egypt, the Russian Federation, the Eurasian Economic Union, New Zealand). At least the WHO initiated a pilot phase for scaling the AUC. For HC widening the limits for AUC is acceptable (no big deal for Cmax; only the PE within 80.0–125.0%).

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