Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-05-24 17:56 CEST (UTC+2h)
 
jag009
Hero

NJ,
2017-10-02 16:12

Posting: # 17844
Views: 758
 

 Exploratory pilot studies without filing IND [Regulatives / Guidelines]

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
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
18,290 posts in 3,889 threads, 1,165 registered users;
18 users online (1 registered, 17 guests).

Facts do not cease to exist because they are ignored.    Aldous Huxley

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed