Analytical Method Transfer Acceptance Criteria
Posted: Wed Jan 12, 2011 12:39 am
Hello,
I am in the process of drafting a method transfer protocol (more importantly trying to set up scientifically sound acceptance criteria) for an assay method and I came across the following article published in LC/GC:
Analytical Method Transfer: http://chromatographyonline.findanalyti ... ?id=387497
The article talks about the acceptance criteria for the assay being "A two one-sided t-test with intersite differences of less than of equal to 2% at 95% CI. I would like to request some help to understand what this statement means. Maybe a case study that shows values and graphical representations of the CI's would help. Thank you very much for reading.
MO
I am in the process of drafting a method transfer protocol (more importantly trying to set up scientifically sound acceptance criteria) for an assay method and I came across the following article published in LC/GC:
Analytical Method Transfer: http://chromatographyonline.findanalyti ... ?id=387497
The article talks about the acceptance criteria for the assay being "A two one-sided t-test with intersite differences of less than of equal to 2% at 95% CI. I would like to request some help to understand what this statement means. Maybe a case study that shows values and graphical representations of the CI's would help. Thank you very much for reading.
MO