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mittyri
Senior

Russia,
2018-06-09 22:39

Posting: # 18878
Views: 570
 

 Virtual Bioequivalence: a myth or coming reality? [Dissolution / BCS / IVIVC]

Dear All!

I was looking into the abstracts published after annual PAGE meeting (and had a pleasure to discuss it with some authors).
I collected some of them here for your review:
1. In vitro-in vivo correlation (IVIVC) population modeling for the in silico bioequivalence of a long-acting release formulation of Progesterone
2. Automatic framework for bioequivalence studies from In Vitro test to In Vivo study design
3. Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles
4. Selecting in vitro dissolution tests using population pharmacokinetic modelling to help bioequivalence studies
5. Bayesian knowledge integration for an in vitro–in vivo correlation (IVIVC) model

The investigators are actively trying to raise the level of the models from in vivo level to in vitro in vivo level.
AFAIK regulatories are also interested and funding some of them.
What do you think? Is time of deconvolution over? Could we see new class A IVIVC using that approach soon?

Kind regards,
Mittyri
jag009
Hero

NJ,
2018-06-13 02:40

@ mittyri
Posting: # 18894
Views: 357
 

 Virtual Bioequivalence: a myth or coming reality?

Hi,

» What do you think? Is time of deconvolution over? Could we see new class A IVIVC using that approach soon?

Afraid so (more or less). I spoke w my former boss who is now working in FDA and he told me about it...

John
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