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Dear All,
We are running one therapeutic equivalence trial in epileptic patients
for US FDA submission.
Generally in bioequivalence study in CRO (under controlled situation),
it is executed only at one site (generally CPU). However our situation
is different.
This is patient trial with
1. No of Sites (hospitals)= 10
2. No of Subjects to be randomized= 28
3. IMP (each bottle contains 100 tablets).
For the planning of the retention of investigational product (IP) and
reference product, we are little held up. As per guideline, we are
expected to retain 5 times.
Now the question is
1. Is it for each site to keep these many units, each of test and
reference?
2. If yes, is it viable?
3. If no, then what is the no of units to be kept at each study
sites?
Thanking you all in advance for your feedback and guidance.
Regards,
Rakesh Dadhania
Project Manager-Clinical Trials
Manipal Acunova Limited.,
Mobius, SJR i-Park, EPIP, Whitefield,
Bangalore - 560 066. India
Email: rakesh.dadhania.-a-.ecronacunova.com
Website : www.ecronacunova.com
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The following message was posted to: PharmPK
The quantity to be retained after study for reference as well as test
product at each site should be 5 times the quantity for Release
specifications (analytical testing carried out before release from the
manufacturing plant)
Ravi
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Please refer the guidance for industry on 'Handling and Retention of
BA and BE Testing Samples'....
Regards,
Dr. Renu Jain
Clinical Research
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