Add-on Studies in RSA [Design Issues]

posted by Ahmed meeran – 2006-08-03 16:38 (6152 d 18:25 ago) – Posting: # 195
Views: 9,157

Dear Mr Helmut,

Thanks for the clarification. This further reinforced in the USFDA guidlines

The US FDA guideline of "Statistical Approaches to Establishing Bioequivalence" mentions:
"If the study is carried out in two or more groups and those groups are studied at different clinical sites, or at the same site but greatly separated in time (months apart, for example), questions may arise as to whether the results from the several groups should be combined in a single analysis. Such cases should be discussed with the appropriate CDER review division."


If clinical part of the study is conducted in 2 parts i.e. first in 12 subjects and then in 12 subjects (if required), there will be problem of group effect, sequence effect, period effect and subject effect.

The MCC South Africa guideline not clearly mentions about clinical or analytical conduct of the study and does not given any statement about statistical approach. Could u pl guide on statistical approach

Complete thread:

UA Flag
 Admin contact
22,620 posts in 4,741 threads, 1,612 registered users;
23 visitors (0 registered, 23 guests [including 9 identified bots]).
Forum time: 11:03 CEST (Europe/Vienna)

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

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