ANVISA's POV on "triangulation points" [Regulatives / Guidelines]

posted by felipeberlinski – Brazil, 2015-03-24 21:37 (3740 d 05:40 ago) – Posting: # 14611
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Dears

It is a grey area.

As I'm not a stat, it would be difficult to point out using calculations.
At this forum there are several members that could give their opinion based on calculation better than me.

However I do agree that no data should be excluded once it was collected correctly. How can assure that? GCP? GLP? Another grey area.

Dear Helmut, ANVISA does not allow re-analysis by PK reasons. So an unexpected behaviour on PK curve should not be re-analyzed due to this, even if you know that the value found its impossible.
Your idea to analize the surrounding points its good but....I cannot foresee an acceptance for it since there are no guidance for such practice.


Solution? :confused:

Lucas: Release two reports, one using all points and another excluding those triangulation points. Go for a meeting and good luck, you'll need!

Regards

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