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There are few issues to consider:
1) Is there a pharmacological interaction between the two drugs? If
there is such an interaction, a BE study based on concentration levels
alone may not be sufficient. A comparative study with
pharmacological/clinical end point should be considered.
2) Is there a pharmacokinetic interaction between the two drugs? If
such an interaction exists it must be characterized before proceeding
to the BE study.
3) The BE study should be as presented in your e-mail: a single-dose
study of your formulation versus 1x20mg IR formulation and 3x2mg
formulation (every 8 hours). The data analysis should be performed
separately on each drug and the corresponding metabolites, if
necessary. Theoretically the BE criteria must be met by AUCs and Cmax
for each drug. The test formulation being a modified-release
formulation a fed BE study should be also performed.
Since the comparison for the second drug is between IR and MR
formulations the criteria for the Cmax parameters may be discussed with
the regulatory agency. It may be expected that the multiple IR and one
MR administration may led to different maximum concentration values.
Hope it helps,
Radu D. Pop
Pharma Medica Research Inc.
966 Pantera Drive
Canada, L4W 2S1
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