Questions -- The
Concept and Criteria of
Please comment on the following
1.If bioinequivalence is demonstrated
for any one pharmacokinetic parameter that is prespecified,
then bioinequivalence is demonstrated for the products.
2.Bioinequivalence must be
demonstrated for all three pharmacokinetic parameters for
bioinequivalence to be demonstrated for the products, where
the error rate is controlled at 5%, and if any one pharmacokinetic parameter is not prespecified.