Bioequivalence and Bioavailability Forum

Dr sridevi
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.
An outlier test is not an expectation of the medicines agencies but outliers could be shown by a box plot. This would allow the medicines agencies to compare the data between them. However, since it is the test product it will be hard to justify the exclusion of the subject from statistical analysis.
Kind regards and good luck
Dan