Bioequivalence and Bioavailability Forum • external predictability for ivivc

external predictability for ivivc [Dissolution / BCS / IVIVC]

posted by yjlee168 – Kaohsiung, Taiwan, 2019-09-09 12:46 (1684 d 00:21 ago) – Posting: # 20556
Views: 6,441

Hi amer,

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

Great to hear that.

❝ ... 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, as far as I can remember, the external predictability (or validation) is not what US-FDA recommended. Usually the internal is recommended.

—
All the best,
-- Yung-jin Lee
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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]
- external predictability for ivivcyjlee168 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