Bioequivalence and Bioavailability Forum

dear all

i would like your opinion on deciding as to how we define that a subject has completed a study in case of replicate design?

Example 1: In case of a 4 period replicate design study, if the subject has completed only 2 periods (one test and one reference) could this subject be considered as having completed the study?

In continuation of the above, if the protocol indicates that all subjects who have completed the study will be included for PK and Stats, should the above subject be included or excluded from PK and Stats?

regards

krishnamurthy