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The following message was posted to: PharmPK
Dear group,
In the CPMP "NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY
AND BIOEQUIVALENCE" it is stated that for C max -ratio that "The 90%
confidence interval for this measure of relative bioavailability
should lie within an acceptance interval of 0.80-1.25. In specific
cases of a narrow therapeutic range the acceptance interval may need
to be tightened. In certain cases a wider interval may be acceptable.
The interval must be prospectively defined e.g. 0.75-1.33 and
justified addressing in particular any safety or efficacy concerns for
patients switched between formulations."
My question is
What is the required justification?
Is it for example
1) No presence of a correlation between conc. and effect or toxicity
2) No difference in the pharmacodynamic properties or adverse events
among different immediate release products having different Cmax values.
3) The drug is a HVD (CV> 30%)
I would appreciate your contribution to this topic.
Mutasim Al-Ghazawi, Ph.D.
Associate professor of pharmacokinetics and statistics
Faculty of Pharmacy
University of Jordan
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The following message was posted to: PharmPK
The main reason,when the reason the Therapeutic Index of the drug in
question is high(wider Terapeutic Index).
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