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Exploratory pilot studies without filing IND [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-10-02 16:12  - Posting: # 17844
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Hi,

Anyone has experience running pilot PK studies without filing an IND in USA?

Specifically, running a pilot study that compares a test product against a reference with the test product having a slight higher dose than the reference given at the maximum total daily dose. The test is designed to have the similar bioavailability(AUC) as the reference and a slower release rate(lower Cmax with longer Tmax).

I don't think it's possible because there is no in-vivo data. I don't think dissolution data alone + info from reference's original NDA about having studies conducted at higher doses would be sufficient. If the test and reference are under the same total daily dose then yes.

Thanks
J

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