PharmPK Discussion - N for single dose formulation NCA PK given once (ever)

• On 19 Nov 2012 at 16:24:12, Paul Hutson (prhutson.-a-.pharmacy.wisc.edu) sent the message
  

  
  The following message was posted to: PharmPK
  
  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
  
  --
  Paul R. Hutson, Pharm.D.
  Associate Professor
  UW School of Pharmacy
  

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