Polymorphism BE [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2011-11-24 11:30 (5330 d 12:39 ago) – Posting: # 7711
Views: 4,643

Dear Ace
IMHO your idea sounds reasonable. But please be advised: First of all you need to know if the originator product shows the same polymorphism. If the originator product is also a mixture of polymorph B with approximately 80% and polymorph A with approximately 20% and if you can demonstrate for the originator product that the polymorph A converts into polymorph B in the same way then you have some strong arguments. If the originator product is a different mixture of polymorph B and polymorph A you need to show if the polymorphs are effective in the same way. Otherwise you have a problem.
I hope this helps
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
320 visitors (0 registered, 320 guests [including 19 identified bots]).
Forum time: 01:09 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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