Using f2 for compounds that never reach 85% dissolution [Dissolution / BCS / IVIVC]

posted by wligtenberg – The Netherlands, 2017-01-17 10:00 (3094 d 06:55 ago) – Posting: # 16962
Views: 6,400

Dear Dr_Dan,

That was a very useful document, thank you.
Although that document does not specifically state how to measure if the products are comparable, we would still need to show that they are. And I cannot imagine that eye-balling the graphs would cut it.
Still, also during development, we would like to have some idea of how different batches compare as well, so I think we would still want some kind of distance measure and a generally accepted cut-off.
But I do get from the document that you linked to, that for liposomes there are no fixed guidelines (yet).

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,698 registered users;
107 visitors (0 registered, 107 guests [including 13 identified bots]).
Forum time: 17:55 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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