Retention of Injection IP's [Regulatives / Guidelines]

posted by Avadhut  – 2009-08-03 15:14 (6174 d 22:08 ago) – Posting: # 4006
Views: 1,889

Dear Sir/Madam,

This is regarding the retention of the investigational Products in the bioavilability and biequivalence studies US submission at CRO SITE.

As in case of the capsules or tablets we retain the 300 unites or 5 times batch release test but for the injection study in which injection is provided in powder form in single vials; how retention should be done, is it 300 vials or is their any other way to calculate the retention samples?

Kindly comment.

Regards,

Avadhut

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