Does the ACPS agree with the distinction between demonstrating bioINequivalence and failure to demonstrate bioequivalence?
The Committee felt that there was a need to separately define bioINequivalence, not just as failure of the bioequivalence test. The members argued it was important to focus on the clinical relevance with the therapeutic index. The Committee discussed both Area under the Curve (AUC) and Cmax as metrics important for bioequivalence and bioINequivalence. 2. Does the ACPS recommend a preferred method for evaluating the three pharmacokinetic parameters for bioINequivalence? If bioINequivalence is demonstrated for any one pharmacokinetic parameter, then bioINequivalence is demonstrated for the products. BioINequivalence must be demonstrated for all three pharmacokinetic parameters for bioINequivalence to be demonstrated for the products. There should be one pre-selected pharmacokinetic parameter used for bioINequivalence testing. If so, which one? The three pharmacokinetic parameters should be evaluated for bioINequivalence with statistical corrections to the level of significance for each p
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- Does the ACPS agree with the distinction between demonstrating bioINequivalence and failure to demonstrate bioequivalence?
- When should comparative clinical trial studies be conducted to demonstrate bioequivalence?
