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Dear All,
This is about reserve samples ( Retention). I would like to know that
it (5 times quantity) is reserved to perform only in-vitro release or
both in-vitro and in-vivo release also which are mentioned in the
application.
Regards,
Francis
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Dear Francis,
The sample should be reserved to perform both the tests
Reference: 21 CFR 320.63
Thanks with regards,
Chintan Mehta
Ranbaxy Lab. Ltd.
Noida
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