Bioequivalence and Bioavailability Forum • Software validation, another round

Software validation, another round [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2019-09-10 17:37 (1853 d 19:21 ago) – Posting: # 20578
Views: 7,361

Hi Yung-jin and amer,

❝ ❝ on the side, just wondering if the ivivc package been validated against standard ivivc software (say WinNonlin?)

❝

❝ Not validated with WLN. Should I? :confused: I do not have WLN. If you have WNL, can you help to validate?

Since the source code of ivivc for R is accessible, one can perform a white box validation. Requires an expert R-coder who is also knowledgeable with the scientific background of IVIVC. An incredibly rare species. Commercial software like the ‘IVIVC Toolkit’ of Phoenix can only be black box validated. If you want to perform cross-validation that would require a couple of reference datasets and hope for the same outcome.

@Yung-jin: Though Certara granted me with a ‘named license’ of Phoenix’ ‘IVIVC Toolkit’, I never used it so far. Furthermore, my experience with ivivc for R are zero.

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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 pH yjlee168 2019-09-10 15:30
    - R scripts/codes for in-vivo conc. yjlee168 2019-09-10 15:13
      - Software validation, another roundHelmut 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