external predictability for ivivc [Dissolution / BCS / IVIVC]

posted by yjlee168 Homepage – Kaohsiung, Taiwan, 2019-09-09 10:46 (609 d 23:26 ago) – Posting: # 20556
Views: 4,526

Hi amer,

» I have conducted IVIVC analysis using the IVIVC for R package, all good!

Great to hear that.

» ... how can i predict the plasma concentrations profile if i have got a new in vitro dissolution profile (not used to establish ivivc) for the same formulation done in a different dissolution media? (i.e going backwards)

If you also had the in-vivo data together with the new dissolution data, would the external predict­ability be the answer for your question? You can select external of 'predictability for ivivc model:' from GUI and then choose the dataset file (03 dataset files (*.csv) for ext. predictability) to run analysis.

However, as far as I can remember, the external predictability (or validation) is not what US-FDA recommended. Usually the internal is recommended.

All the best,
-- Yung-jin Lee
bear v2.9.0:- created by Hsin-ya Lee & Yung-jin Lee
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