Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-22 02:09 CEST (UTC+2h)

Exploratory pilot studies without filing IND [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-10-02 16:12  - Posting: # 17844
Views: 782

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,413 posts in 3,912 threads, 1,175 registered users;
online 34 (0 registered, 34 guests [including 28 identified bots]).

The greatest shortcoming of the human race is our inability
to understand the exponential function.    Albert Bartlett

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed