Bioequivalence and Bioavailability Forum • Dabigatran EMA

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

posted by Helmut – Vienna, Austria, 2019-02-14 14:52 (2221 d 16:59 ago) – Posting: # 19920
Views: 5,420

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 C_max; only the PE within 80.0–125.0%).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Dabigatran EMA - product-specific guide nobody 2019-02-13 18:58 [Regulatives / Guidelines]
- Dabigatran EMA - product-specific guide ElMaestro 2019-02-13 22:59
  - OT: A major loss Helmut 2019-02-14 00:24
    - OT: A major loss nobody 2019-02-14 09:31
      - OT: A major loss Helmut 2019-02-14 11:37
        
        OT: A major loss nobody 2019-02-14 13:40
- Dabigatran EMA - product-specific guide Helmut 2019-02-14 12:12
  - Dabigatran EMA - product-specific guide nobody 2019-02-14 13:34
    - Dabigatran EMA - product-specific guideHelmut 2019-02-14 13:52
      - Dabigatran EMA - product-specific guide nobody 2019-02-14 15:01