external predictability for ivivc [Dissolution / BCS / IVIVC]

posted by amer – Australia, 2019-09-10 02:31 (1074 d 08:23 ago) – Posting: # 20568
Views: 5,431

Hi Lee,

Thank you for you answer.

» » ... 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, i didnt actually mean external validation. What i meant is this: I have constructed IVIVC using in vivo data and dissolution data done at pH 1.2. if i have a new dissolution data (say done at pH 2), how can i predict the in vivo concentrations based on the new dissolution (i.e. does ivivc for R does convulution where the input is the dissolution data and we want to predict the output which is plasma concentration profile?).

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

Thanks for the info.
on the side, just wondering if the ivivc package been validated against standard ivivc software (say WinNonlin?)

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