Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-11-07 19:52 (709 d 10:42 ago) – Posting: # 20762
Views: 2,351

Hi,

» Please, I would like to know that, with the In vitro comparative dissolution study report can we waive off BE In vivo study with in vitro comparative dissolution study for the lower strength for Mycophenolate mofetil tablet 250mg or do we require separate BE study for the lower strength.

Are the strengths formulation proportional? FDA or EMA?

» And also I would like to know that whether similar approach can be taken for all the pro-drug where the metabolite of the drug is pharmacologically active.

FDA yes. Take a look at enalapril BE guidance.

J

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Sunday 07:34 CEST (Europe/Vienna)

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

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