•Do you agree with the distinction between demonstrating bio-inequivalence and failure to
•What is your preferred method for evaluating the three pharmacokinetic parameters for
–If bio-inequivalence is
demonstrated for any one pharmacokinetic parameter, then bio-inequivalence is demonstrated for the products.
–bio-inequivalence must be
demonstrated for all three pharmacokinetic parameters
for bio-inequivalence to be demonstrated for the products.
–There should be one
preselected pharmacokinetic parameter used for bio-inequivalence
testing. If so, which one?
–The three pharmacokinetic
parameters should be evaluated for bio-inequivalence with statistical corrections to the level
of significance for each parameter in order to maintain an overall
significance level of 0.05.
- Questions - BioINequivalence
– Concept and Definition