Bioequivalence and Bioavailability Forum • Steady state most sensitive: in some particular cases

Steady state most sensitive: in some particular cases – yes [Design Issues]

posted by ElMaestro – Denmark, 2011-11-03 13:28 (5349 d 07:59 ago) – Posting: # 7592
Views: 3,650

Hi HS,

❝ Some basic work was done by the FDA^1,2 and recently by a Spanish group.^3,4 Note one of the co-authors. ;-)

Ah, so we can't get approvals on basis of simulations but regulators can use simulations to define regulatory requirements :confused:

?!

Best regards,
EM.

Most sensitive The Outlaw Torn 2011-11-02 12:49
- Steady state most sensitive: in some particular cases – yes Helmut 2011-11-02 15:31
  - Steady state most sensitive: in some particular cases – yes The Outlaw Torn 2011-11-03 12:26
  - Steady state most sensitive: in some particular cases – yesElMaestro 2011-11-03 12:28
    - Why, oh why? Helmut 2011-11-03 14:46