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analytical method validation.. robustness? - what do u do as robustness..?? purpose of it?? (Aug/24/2007 )

hi allll...

i wanna know what the purpose of robustness is.. for any analytical mehtod vallidation. and what all do u do in such a study?
i work on protien methods.. but any discussion on any methods wil b invidted by me!



Robustness refers to the reproducability of the methd on different instruments. Also to different operators using the same instrument. Also, to using the same instrument & operator but at different times (does ambient temperature affect the assay, does stray sunlight etc). And so on.

You could also agrue that robustness takes account of different sample types (diff cells or tissues?) Different anti-coagulants in blood tubes (fluoride oxalate, gel, Li hep, EDTA). There is a matrix effect with some samples not seen in others. e.g. venous glucose is different in plasma compared to serum.

Ideally whatever you do to your assay conditions and whoever does it the CVs should all be comparable. Likewise, sensitivity, limit of detection and linearity should all be the same. That's why you check the assay with a calibration curve and Quality Control material.

This is a fascinating aspect of analytical science that uses statistics and an understanding of standardisation together with the limitations of these as well as the effects of biological and analytical variation.

Nice question!