software: NCA not validated [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2019-02-16 13:59  – Posting: # 19928
Views: 694

Hi Nasty,

» […] it turns out that in some rare extreme cases it is worth to think about alternative approaches. Would it be accepted?

As I said numerous times – if described in the protocol – yes.

» How to be sure that the method stated in SAP would work better than PHX algo? Is it possible to explain in the report any disagreement with PHX output?

Good questions. No software is validated when it comes to NCA. Assessors/inspectors are you aware of it? See my attempt there.
For years the NCA Consortium is struggling to come up with sumfink. You have to apply for membership; interesting enough the majority of members are coming from originators or the academia. The task turned out to be rather difficult…

Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,280 posts in 4,099 threads, 1,315 registered users;
online 10 (1 registered, 9 guests [including 8 identified bots]).

It’s easy to lie with statistics;
it is easier to lie without them.    Frederick Mosteller

BEBAC Ing. Helmut Schütz