Bioequivalence and Bioavailability Forum

Dear Yura
Ideally, all treated subjects should be included in the statistical analysis. However, subjects in a crossover trial who do not provide evaluable data for both of the test and reference products (or who fail to provide evaluable data for the single period in a parallel group trial) should not be included. In principle any reason for exclusion of a subject from statistical evaluation is valid provided it is specified in the protocol and the decision to exclude is made before bioanalysis. Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
I hope this helps.
Kind regards
Dr_Dan