Regulators truncated [NCA / SHAM]

posted by Ohlbe – France, 2009-06-18 08:37  – Posting: # 3874
Views: 17,612

Dear D. Labes,

» Regulators response:
» The Germans asked for AUC(0-inf)!
» The French asked for lamdaZ (kel) and t1/2!
»
» Hopefully they will not ask for residual area <20% :angry: .

I hesitate between :rotfl: and :crying:

Regards
Ohlbe

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
20,142 posts in 4,248 threads, 1,387 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 14:22 UTC

Maturity is the capacity to endure uncertainty.    John Finley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5