Posting: # 17844
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.