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- Questions - Bio IN equivalence – Concept and Definition

- Questions - Bio IN equivalence – Concept and Definition. Do you agree with the distinction between demonstrating bio-inequivalence and failure to demonstrate bioequivalence? What is your preferred mthod for evaluating the three pharmacokinetic parameters for bio-inequivalence?

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- Questions - Bio IN equivalence – Concept and Definition

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  1. - Questions -BioINequivalence – Concept and Definition • Do you agree with the distinction between demonstrating bio-inequivalence and failure to demonstrate bioequivalence? • What is your preferred mthod for evaluating the three pharmacokinetic parameters for bio-inequivalence? • 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.

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