external predictability for ivivc [Dissolution / BCS / IVIVC]

posted by amer – Australia, 2019-09-10 02:31  – Posting: # 20568
Views: 2,713

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?)

Complete thread:

Activity
 Admin contact
20,643 posts in 4,328 threads, 1,436 registered users;
online 18 (0 registered, 18 guests [including 5 identified bots]).
Forum time: 19:41 CEST (Europe/Vienna)

Don’t undertake a project
unless it’s manifestly important
and nearly impossible.    Edwin H. Land

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