Bioequivalence and Bioavailability Forum • identical pH

identical pH [Dissolution / BCS / IVIVC]

posted by yjlee168 – Kaohsiung, Taiwan, 2019-09-10 17:30 (2125 d 14:06 ago) – Posting: # 20577
Views: 10,150

Dear Helmut,

❝ ... Valid predictions based on IVIVC require dissolution at identical pH values. Repeat the exercise at \(\small{pH\;1.2}\).

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.

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All the best,
-- Yung-jin Lee
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Complete thread:

predicting in vivo PK profiles from in vitro data after establishing IVIVC amer 2019-09-09 05:04 [Dissolution / BCS / IVIVC]
- 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
      - 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