failed bioequivalence study [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2009-05-24 16:48 (6242 d 03:45 ago) – Posting: # 3743
Views: 4,880

Hi AMR,

❝ the geometric mean ratio for main pK parameters was less than 80%


It sounds to me like the formulations are not really equivalent, so reformulation is imho the way forward.

Best regards
EM.

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
391 visitors (0 registered, 391 guests [including 18 identified bots]).
Forum time: 20:33 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

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