Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-10-02 08:56 (847 d 04:35 ago) – Posting: # 19359
Views: 4,306

Do as others have said, Amalia.

Follow section 4.2 of the Guideline. When it points you to appendix III, ignore the BCS-biowaiver stuff. Focus on the first third of the information on page 27 only (about experimental conditions). In other words, don't think BCS or solubility or permeability or API or anything else. Do the standard comparative dissolution testing at 3 pH values for your finished drug product at all strengths, etc.

Complete thread:

Activity
 Admin contact
21,314 posts in 4,446 threads, 1,489 registered users;
online 7 (1 registered, 6 guests [including 4 identified bots]).
Forum time: Tuesday 12:31 CET (Europe/Vienna)

Any one who considers arithmetical methods
of producing random digits is, of course,
in a state of sin.    John von Neumann

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