Polymorphism BE [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2011-11-24 11:30 (5311 d 05:57 ago) – Posting: # 7711
Views: 4,600

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
23,653 posts in 4,991 threads, 1,570 registered users;
145 visitors (0 registered, 145 guests [including 29 identified bots]).
Forum time: 18:28 CEST (Europe/Vienna)

The epistemological value of probability theory is based on the fact
that chance phenomena, considered collectively and on a grand scale,
create non-random regularity.    Andrey Kolmogorov

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