Need of cross validation between 2 different cc range [Bioanalytics]

posted by ElMaestro  – Belgium?, 2018-07-25 09:33 (827 d 05:55 ago) – Posting: # 19095
Views: 1,650

Hello Lmsmqa,

excellent topic to bring up, actually.
Strictly speaking the residuals in your model will be affected by the bioanalytical method, i.e. they are not necessarily IID within or between.
Having said that, there are so many other assumptions in this game that I believe that if both assays are individually passing the validation criteria then there is no big issue and I don't have worry to the extent that I would think it is in the patient's interest to have additional crossvalidation. But I cannot qualify it further, it is gut feeling only.
Possibly one could specify method as a fixed factor with two levels in the model. This could at least be said to (try to) take bioanalytical accuracy differences into account but not precision differences.

I could be wrong, but...

Best regards,
ElMaestro

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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