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Registeridentical pH [Dissolution / BCS / IVIVC]
posted by yjlee168 
– Kaohsiung, Taiwan, 2019-09-10 15:30 (447 d 07:26 ago) – Posting: # 20577
Views: 3,739
Dear Helmut,
» ... Valid predictions based on IVIVC require dissolution at identical pH values. Repeat the exercise at pH 1.2.
I had the same though as yours before. Then I think the new pH dissolution profile seems possible to predict in-vivo conc. That's because once the iv-vitro and in-vivo correlation is established, FRD (fraction dissolved; from dissolution profile) obtained from a new pH media can be used to estimate Fab (Fraction absorbed) from established ivivc. So it becomes possible to predict in-vivo conc. with known kel and Vd from the previous Wagner-Nelson method. All calculation steps are part of model validation in ivivc for R.
» ... Valid predictions based on IVIVC require dissolution at identical pH values. Repeat the exercise at pH 1.2.
I had the same though as yours before. Then I think the new pH dissolution profile seems possible to predict in-vivo conc. That's because once the iv-vitro and in-vivo correlation is established, FRD (fraction dissolved; from dissolution profile) obtained from a new pH media can be used to estimate Fab (Fraction absorbed) from established ivivc. So it becomes possible to predict in-vivo conc. with known kel and Vd from the previous Wagner-Nelson method. All calculation steps are part of model validation in ivivc for R.
—
All the best,
-- Yung-jin Lee
bear v2.8.9:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
Download link (updated) -> here
All the best,
-- Yung-jin Lee
bear v2.8.9:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
Download link (updated) -> here
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 ivivc amer 2019-09-10 02:31
- identical pH Helmut 2019-09-10 10:58
- identical pHyjlee168 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 ivivc amer 2019-09-10 02:31
- external predictability for ivivc yjlee168 2019-09-09 10:46
Ing. Helmut Schütz