Add-on Studies / Sequential Design [Design Issues]

posted by Ahmed meeran – 2006-07-27 10:56 (6454 d 14:06 ago) – Posting: # 189
Views: 9,509

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
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
77 visitors (0 registered, 77 guests [including 10 identified bots]).
Forum time: 00:03 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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