IVRT or IVPT BE studies [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-07-22 22:59 (638 d 04:12 ago) – Posting: # 20430
Views: 996

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
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 11 (0 registered, 11 guests [including 5 identified bots]).
Forum time: Wednesday 03:11 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5