Yes it went a little fast [Bioanalytics]

posted by ElMaestro  – Belgium?, 2018-11-07 15:22 (755 d 09:39 ago) – Posting: # 19543
Views: 4,822

Hi Helmut,

» IMHO, calculating the S:N is no more than a finger excercise unless required by the method (e.g., traces in accredited environmental analysis where a true blank matrix does not exist).

Yes I think this is my point stated in oher words. There is no universally agreed method to define s:n so as a consequence it is hardly effective or relevant to have a rule about its quantity.

» In bioanalytical methods I'm not sure whether it should be part of an (optional anyway) system suitability test. Playing the devil's advocate - two methods, A/P at the LLOQ 20/20%, S/N 10 or 15/15 5?

I don't follow this terminology, can you explain what you mean? My hindsight is 20/20.
S:N is done at the LLOQ, as far as I know. If it is "good enough" at the LLOQ then it is supposedly also "good enough" (whatever that means) anywhere above the LLOQ.

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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