Add-on Studies / Sequential Design [Design Issues]

posted by Ahmed meeran – 2006-07-27 10:56 (6572 d 15:18 ago) – Posting: # 189
Views: 9,889

Dear joyjac

Only South Africa and Japan authorities approve such a study. Acc SA it should be stated in protocol before the beginning of the study. No of subjects should not exceed twice than orginal for eg if we begin the study with 12 volunteers then the maximum add ons permitted is 24. (Biostudies guidlines of SA and Addendum 5 to the biostudies). But what is not clear is whether we should do the clinical part for the entire study at first (eg for all the 24) and do the analytical part for the 12 only and to perfom the study on other 12 only if the study fails. If any body knows please clear.

Complete thread:

UA Flag
 Admin contact
23,127 posts in 4,859 threads, 1,646 registered users;
44 visitors (0 registered, 44 guests [including 9 identified bots]).
Forum time: 02:15 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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