statistical evaluations [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2017-02-18 13:44 (2918 d 21:52 ago) – Posting: # 17082
Views: 3,162

Hi rajasekhar,

❝ Is there any regulation for minimum measurable concentrations to perform statistical analysis. please let me know is there any supportive guidelines for same.


This is where you need an SOP and not a guideline.
Wit three values above the LLOQ the profile for that subject's data is rubbish but in the absence of an SOP you may need to include it still. Perhaps the EMA's Cmax:LLOQ requirement comes to some degree of rescue.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,665 registered users;
86 visitors (0 registered, 86 guests [including 7 identified bots]).
Forum time: 11:37 CET (Europe/Vienna)

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

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