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

posted by Helmut Homepage – Vienna, Austria, 2019-02-14 13:52  – Posting: # 19920
Views: 1,043

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%).

Cheers,
Helmut Schütz
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