PharmPK Discussion - Reserve drug samples to be shipped to the clinical site

• On 13 Sep 2012 at 12:53:57, SE Det (sedet99.at.gmail.com) sent the message
  

  
  Hello,
  
  I have a quesiton that I was hoping someone could assist me with or put me in
  contact with someone who could. It is in regard to calculating reserve drug
  samples to be shipped to the clinical site.
  
  The BE FDA guidance document for sample retention  says that the quantity of
  reserve samples should be sufficient to permit the Agency to perform 5 times all
  of the release tests required in the application or supplemental application.
  But  the Q&A final rule, April 28, 1993, Part III 58 FR 25918 states that -The
  quantity of sample required to be retained is sufficient for all testing by FDA
  including a repeat of a bioavailability or bioequivalence study, if necessary.
  
  If there are 100 subjects in a single dose 3 period crossover study (2 ref, 1
  test) and 2 vials needed for each dose how many retain samples of each are
  needed?  5 x release testing only comes to 50 drug vials for Ref product and 200
  drug vials for Test product. Is this sufficient? I have always used 5 x number
  of subjects (or 300 cap for each drug for solid oral) but was looking for
  confirmation and only found the 1 document. I also asked a couple of  others in
  industry and they said they routinely used 5 x the number of subjects as well.
  
  Can you please tell me where I can find a clear cut answer or documents that
  clearly define how to calculate how many retain samples are needed?
  

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