Bioequivalence and Bioavailability Forum 06:39 CET

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

posted by nobody - 2019-02-14 15:01  - Posting: # 19921
Views: 190

» » » 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
» »
»
» 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...

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 guide - Helmut, 2019-02-14 13:52
        • Dabigatran EMA - product-specific guide - nobody, 2019-02-14 15:01