secondary parameters [NCA / SHAM]

posted by Cmax – India, 2011-07-03 11:08 (5054 d 06:16 ago) – Posting: # 7202
Views: 4,686

Hello...
what is the fun in reporting seconary parameters in the generic submission... we are only concerned about Cmax & AUC 90 CI. regulators evaluate this. :confused:

and in pilot study how it helps interpretation...
regards
cmax...


Edit: Category changed. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,666 registered users;
53 visitors (0 registered, 53 guests [including 7 identified bots]).
Forum time: 17:25 CEST (Europe/Vienna)

Patients may recover in spite of drugs or because of them.    John Gaddum

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