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The following message was posted to: PharmPK
Dear all,
We are currently designing a so called cocktail trial to investigate the
effect of our compound on the metabolism (CYP450s) of five probe
compounds.
It will be a cross-over trial in which the probes are given once
together
with our compound and once alone. Parent/metabolite ratios in both
treatments will be indicative for the extent of the effect. To prove no
effect the trial should be powered according to bioequivalence criteria
(same as regular drug interaction studies). In case 'no effect' is
proven
for a probe, no additional drug interaction studies with drugs
metabolized
following the P450 route of that specific probe would be needed. Does
anyone
know how regulatory authorities are dealing with this matter.
Kind regards,
Huub
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)