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I have been asked to design a PK study for a non-profit for an experimental (but
old) orally administered drug that is given just once (ever). Drug is not toxic
though, and could be redosed for a pK study if required. Dose finding has
already been done on an ad hoc formulation (API weighed into capsules per
patient), but we plan to do formal PK on a product incorporating the Wurster
method to avoid issues with crystal size in the final mass-produced formulation.
1. Can anyone provide guidance on how many subjects are needed in such a trial?
I don't find it in the FDA or ICH guidance.
2. Can anyone think of another oral drug that is given just once (ever), that I
might use as a template for an NCA PK study sample size?
3. Do you think I would need to do a cross-over with the new formulation to show
that the dose selected based upon the current, extemporaneous capsule (with no
prior PK) is valid with the new formulation?
Thanks in advance.
Paul R. Hutson, Pharm.D.
UW School of Pharmacy
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