Regulators truncated [NCA / SHAM]

posted by Ohlbe – France, 2009-06-18 10:37  – Posting: # 3874
Views: 18,756

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
20,817 posts in 4,356 threads, 1,447 registered users;
online 15 (0 registered, 15 guests [including 8 identified bots]).
Forum time: 17:41 CEST (Europe/Vienna)

Repetition does not transform a lie into a truth.    Franklin D. Roosevelt

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