‘Add-on’ design? [Study Per­for­mance]

posted by nlpati – India, 2018-02-22 08:12  – Posting: # 18445
Views: 2,700

(edited by Ohlbe on 2018-02-22 10:02)

Hi Helmut,

» I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed?

Study is completed and wants to do additional study with some additional subjects and planning to retrieve IPs from previous passed study. For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.

with regards,
Lakshmipathy


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Activity
 Admin contact
20,134 posts in 4,245 threads, 1,386 registered users;
online 19 (2 registered, 17 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 18:07 CET

A Camel is a Horse designed by committee.    Anonymous

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