identical pH [Dissolution / BCS / IVIVC]

posted by yjlee168 Homepage – Kaohsiung, Taiwan, 2019-09-10 15:30 (380 d 05:12 ago) – Posting: # 20577
Views: 3,500

Dear Helmut,

» ... Valid predictions based on IVIVC require dissolution at identical pH values. Repeat the exercise at pH 1.2.

I had the same though as yours before. Then I think the new pH dissolution profile seems possible to predict in-vivo conc. That's because once the iv-vitro and in-vivo correlation is established, FRD (fraction dissolved; from dissolution profile) obtained from a new pH media can be used to estimate Fab (Fraction absorbed) from established ivivc. So it becomes possible to predict in-vivo conc. with known kel and Vd from the previous Wagner-Nelson method. All calculation steps are part of model validation in ivivc for R.

All the best,
-- Yung-jin Lee
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