Bioequivalence and Bioavailability Forum

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."

THIS SHOWS FDA MAY NOT ENCOURAGE ADD ON

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