IVRT or IVPT BE studies [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-07-22 22:59  – Posting: # 20430
Views: 199

Hi,

A strange Q(I know the answer but I was wondering if i am wrong).
Is it possible to run IVRT or IVPT BE studies on two products that are of different strengths? ie: The test is a 2% cream and the RLD is a 10% cream. Why? RLD is not available as a 2% cream. Would the results be acceptable for regulatory filing (FDA or EMA)?

Thx
J

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,688 posts in 4,178 threads, 1,353 registered users;
online 11 (0 registered, 11 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 19:56 CEST

Power. That which statisticians are always calculating
but never have.    Stephen Senn

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