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Understanding Bioinequivalence: Concepts, Definitions, and Evaluation Methods

This document explores the concept of bioinequivalence, highlighting its definition and critical distinctions from bioequivalence studies. It poses questions regarding the evaluation methods for pharmacokinetic parameters and emphasizes the necessity of demonstrating bioinequivalence across all three parameters for valid conclusions. Additionally, it discusses the importance of selecting a preselected pharmacokinetic parameter for testing and recommends statistical corrections to maintain an overall significance level of 0.05 in bioinequivalence assessments.

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Understanding Bioinequivalence: Concepts, Definitions, and Evaluation Methods

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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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