How to show similarity if solubility is low? [Dissolution / BCS / IVIVC]

posted by luvblooms  – India, 2015-03-20 05:34 (4108 d 19:52 ago) – Posting: # 14583
Views: 11,212

Hi Nobody

❝ This here looks quite experimental: http://www.ncbi.nlm.nih.gov/pubmed/23058042

❝

❝ Any experience on regulatory acceptance for this approach yet?


as per "Guidance for Industry Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations" page 8 of 27

"In general, nonaqueous and hydroalcoholic systems (apart from alcohal dose dumping) are discouraged unless all attempts with aqueous media are unsuccessful. Appropriate review staff in CDER should be consulted before using any other media" so we never tried them for submission purpose but yes, have used this extensively for discrimination of CR products.

do check
  1. this and
  2. this
—
~A happy Soul~

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
112 visitors (0 registered, 112 guests [including 17 identified bots]).
Forum time: 02:27 CEST (Europe/Vienna)

Actually, science starts to become interesting
only where it ends.    Justus von Liebig

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