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Dear David and All,
The quantity of reserve samples should be sufficient to permit the
Agency to perform five times
all of the release tests required in the application or supplemental
Que.:The quantity of reserve samples should be five times of what?
I want to know, How the five times quantity reserve sample
requirement is met in following case?
Eg.Below is a suggested packaging and random selection plan for a
blinded, multisite study of a
dermatological cream product involving a SMO:
The study enrolls 300 subjects with approximately 60 subjects at five
testing facilities. The five times quantity for the test article and
standard is 50 tubes for each product. In preparation for conducting the
study, the SMO prepares 200 boxes that contain one code-labeled tube of
test article and one code-labeled tube of reference standard in each
The SMO randomly distributes 40 boxes to each clinical testing facility.
The clinical facility randomly selects 30 of the boxes to dose 60
The remaining 10 boxes serve as the reserve samples. In this example,
staff (e.g., a pharmacist) not involved with the study may be
to ensure the study remains blinded. This packaging system ensures
equal number of test article and reference standard are administered
subjects at each site, and that an equal number of test article and
standard will be maintained as reserve samples. Since 10 boxes are
each of 5 testing facilities, 50 tubes each of test article and
standard are retained and the five times quantity reserve sample
requirement is met. In addition, the requirement of random selection by
each testing facility is also met.
Can anyone explain this ?
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