one size fits all vs goal posts [NCA / SHAM]

posted by Astea – Russia, 2019-02-16 08:33  – Posting: # 19926
Views: 1,247

Dear Mittyri!

Thank you for your remarkable example! I've got it. But there could be some phylosophical thoughts: may be 60 is a miss (error or samples were mixed) than what whould be better - to calculate the square under 30-60-2 triangle carefully or to calculate the square under the curve assuming log elimination? If we have a large sample size in the study and noone presents the same pharmacokinetic features than it's a reason to think what that could be.

» I don't think the default WNL NCA rules will change since it can break a lot of templates and projects. Name it as unhealthy and lazy conservatism ;-)

Don't believe in it cause I observe a lot of changes and improvements while using PHX through years :-)

Another point is that I used PHX NCA like a standard candle (maybe regulators do it as well?). But it turns out that in some rare extreme cases it is worth to think about alternative approaches. Would it be accepted? 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?

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