no way out for NCA validation? [NCA / SHAM]

posted by mittyri – Russia, 2019-02-20 21:22  – Posting: # 19949
Views: 4,759

Hi Helmut,

from your lecture:
‘Black box’ validation
  • Run datasets with certified results (e.g., from NIST’s Statistical Reference Datasets Project).
    – FDA (2002)
    • Testing with usual inputs is necessary.
    • However, testing a software product only with expected, valid inputs does not thoroughly test that software product.
    • By itself, normal case testing cannot provide sufficient confidence in the dependability of the software product.

  • Create ‘worst-case’ datasets (extreme range of input, enter floating point numbers to integer fields, enter characters to numeric fields…).


So what is the problem to validate WNL NCA using the datasets (OK, not only from literature since there are so many troubles as you showed, but some simulated)?
All rules are written in the User's guide, so it could be crosschecked against handmade R code. Or should it be validated against another validated software (which does not exist)?

Kind regards,
Mittyri

Complete thread:

Activity
 Admin contact
20,796 posts in 4,354 threads, 1,446 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: 19:21 CEST (Europe/Vienna)

I’m not a pessimist,
I’m just a well informed optimist.    José Saramago

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5