Bioequivalence and Bioavailability Forum

EMEA Widening of acceptance limit [Regulatives / Guidelines]

posted by mittyri  – Russia, 2015-02-03 14:16 (4158 d 17:53 ago) – Posting: # 14363
Views: 3,246

Dear Dr.Dan & All,

I apologize for leveling up so old thread, but I didn't find any additional topics.

❝ IMHO you just have to point out in the protocol that the drug has no narrow therapeutic window and that a slightly higher variability of Cmax will not raise any safety concerns.

Is it really enough as sound clinical justification? It doesn't look so...
Can someone help with additional requirements or examples?

PS: The link to the presentation above is broken

Complete thread:

• EMEA Widening of acceptance limit hiren379 2012-05-02 08:39 
  • EMEA Widening of acceptance limit Dr_Dan 2012-05-02 09:28
    • EMEA Widening of acceptance limit hiren379 2012-05-10 10:37
      • EMEA Widening of acceptance limit akinapally 2012-05-10 13:22
    • EMEA Widening of acceptance limitmittyri 2015-02-03 13:16