Bioequivalence and Bioavailability Forum • predicting in vivo PK profiles from in vitro data after establishing IVIVC

predicting in vivo PK profiles from in vitro data after establishing IVIVC [Dissolution / BCS / IVIVC]

posted by amer – Australia, 2019-09-09 07:04 (2068 d 22:32 ago) – Posting: # 20555
Views: 10,554

I have conducted IVIVC analysis using the IVIVC for R package, all good!

Now that I have estabished IVIVC levy plots (and regression equation); 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)

For the new dissolution data (not used to establish ivivc), i can calulate the predicted fraction absorbed using the regression equation from the constructed IVIVC. But then, how can i predict the in vivo plasma Pk profile from the predicted fraction absorbed? does the ivivc for R package do that? how? what is the r-script that i can use.

I am using R studio.

Thanks,

Complete thread:

predicting in vivo PK profiles from in vitro data after establishing IVIVCamer 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 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
      - 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