An example of IS response. [Bioanalytics]

posted by Ohlbe – France, 2020-05-26 17:27 (327 d 08:26 ago) – Posting: # 21478
Views: 5,288

Dear Shuanghe,

» I would make a suggestion to the CRO for the modification of their SOP to take incidence like this into consideration. One way is like you said, repeat another set of CC at the end. What else can we do to improve it?

They should read the FDA Q&A, but it does not help much here (there are some QC samples with an IS response tracking that of the subject samples).

They should also look at the special issue of Bioanalysis on this topic. It includes papers from both regulators and industry, with nice case studies. The overall conclusion is: acceptance criteria such as mean ± x% are useful, but not in all situations. Plotting the IS response to look for trends and systematic differences is a must.

Also a nice review, just published in the same journal, free access :-).


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