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The following message was posted to: PharmPK
Dear group
I have a question on the possibility of conducting bioequivalence
studies on anticancer drugs using healthy volunteers. I know that in
general studies on such products should be conducted using patients.
However, an article entitled "Bioequivalence, safety, and tolerability
of imatinib tablets compared with capsules" that was published in
"Cancer Chemother Pharmacol (2004) 53: 433-438"
Shows that healthy volunteers participated in the study and the drug
was administered on three phases (3 times).
My question is on the acceptance of regulatory agencies and experience
on the issue of conducting BE studies of anticancer agents in healthy
volunteers in general and for this drug "imatinib" in particular.
Thanks
Dr. Mutasim A. Al-Ghazawi
Associate Professor of Pharmacokinetics
Faculty of Pharmacy
University of Jordan
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The following message was posted to: PharmPK
Dr. Al-Ghazawi:
There is a wide range of therapeutic ranges among the antineoplastic
agents. The kinase inhibitors, specifically the tyrosine kinase
inhibitors that include imatinib, are less toxic than other classes of
antineoplastics. Theoretically, a single dose of less toxic
antineoplastics could be given to healthy volunteers. Yet even if you
look at the more recently approved kinase inhibitors you will see that
they experienced high rates of adverse events when they folowed this
practice especially in their QTc studies. So my general address would
be no, not usually. Your best course of action would be to talk to the
regulatory agency where you plan to file your bioequivalence study
before actually designing your study.
Sincerely,
Carol Collins MD
Senior Research Scientist
University of Washington
Seattle, Washington
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