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For a drug-drug interaction study, the strong CYP 3A4 inhibitor (perpetrator) exposure should be
long enough to cover the AUCo-inf of the substrate (in this case about 60 days as its half-life is
10 days). This would mean 60 days of exposure to a strong CYP 3A4 inhibitor in normal volunteers
which we’d like to obviously avoid. What type of study design could be done to circumvent this.
I look forward to your comments.
Martine Allard, RPh, PhD
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