Bioequivalence criteria for study [Regulatives / Guidelines]

posted by Dr.Pravin – Ahmedabad, 2006-12-06 15:17 (6733 d 23:59 ago) – Posting: # 382
Views: 4,928

I am conducting one study of highly variable drug for EU, i have defineed the range for the BE limit is 80 to 125% for that drug. The problem is that i have completed the one period of that study, now i want to change the BE criteria, so what is more fesible, protocol deviation or protocol amendment?
—
Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
141 visitors (0 registered, 141 guests [including 3 identified bots]).
Forum time: 16:17 CEST (Europe/Vienna)

Only dead fish go with the current.    Scuba divers' proverb

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