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Registerexternal predictability for ivivc [Dissolution / BCS / IVIVC]
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)
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» 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?)
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:
- predicting in vivo PK profiles from in vitro data after establishing IVIVC amer 2019-09-09 05:04 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- external predictability for ivivc yjlee168 2019-09-09 10:46
- external predictability for ivivcamer 2019-09-10 02:31
- identical pH Helmut 2019-09-10 10:58
- identical pH yjlee168 2019-09-10 15:30
- R scripts/codes for in-vivo conc. yjlee168 2019-09-10 15:13
- Software validation, another round Helmut 2019-09-10 15:37
- Deconvolution mittyri 2019-09-10 15:54
- Software validation, another round yjlee168 2019-09-11 10:29
- Software validation, another round Helmut 2019-09-11 13:39
- Software validation, another round amer 2019-09-12 05:26
- Should we also consider to validate the validation? yjlee168 2019-09-12 09:46
- Who inspects the inspectors? Helmut 2019-09-13 12:07
- Who inspects the inspectors? nobody 2019-09-13 12:55
- Sapienti sat Helmut 2019-09-13 12:59
- Who inspects the inspectors? nobody 2019-09-13 12:55
- Who inspects the inspectors? Helmut 2019-09-13 12:07
- Should we also consider to validate the validation? yjlee168 2019-09-12 09:46
- Software validation, another round amer 2019-09-12 05:26
- Software validation, another round Helmut 2019-09-11 13:39
- R scripts/codes for in-vivo conc. amer 2019-09-11 05:35
- Bioavailabity term in predicted in-vivo conc. yjlee168 2019-09-11 10:16
- Software validation, another round Helmut 2019-09-10 15:37
- identical pH Helmut 2019-09-10 10:58
- external predictability for ivivcamer 2019-09-10 02:31
- external predictability for ivivc yjlee168 2019-09-09 10:46
Ing. Helmut Schütz