Replicate Study designs [Outliers]

posted by Dr_Dan  – Germany, 2014-01-08 16:24 (3817 d 01:10 ago) – Posting: # 12149
Views: 13,830

Dear Mahesh M
Just for clarification: when I talked about outlier verification I did not mean a statistical test but rather a re-dose study (you administer test and reference in a cross-over design in the outlying subjects together with a certain number of other study participants). However this is only possible for FDA submissions. For EU submissions Ohlbe is right, the study failed.
Kind regards

Kind regards and have a nice day

Complete thread:

UA Flag
 Admin contact
23,059 posts in 4,841 threads, 1,665 registered users;
36 visitors (0 registered, 36 guests [including 6 identified bots]).
Forum time: 18:34 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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