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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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