IVRT or IVPT BE studies [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-07-22 22:59 (383 d 17:58 ago) – Posting: # 20430
Views: 824

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
20,986 posts in 4,375 threads, 1,460 registered users;
online 13 (0 registered, 13 guests [including 8 identified bots]).
Forum time: Sunday 16:57 CEST (Europe/Vienna)

The interpretation of facts in a certain way
stimulates other scientists’ thoughts.    Róbert Bárány

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