Posting: # 18759
Please share your experience/view on below points. Thank you in advance.
1. Is it acceptable regulatory point of view (AnVIsa, EMA), If we identify haemolysed samples with it's grade (severe, moderate, slightly) during sample receipt in bioanalytical lab instead of haemolysed sample identification at clinical stage during sample separation as per defined procedure in SOP.
2. As per ANVISA requirements: is it required to evaluate ECG by cardiologist in BA/BE Study or ECG evaluation by medical qualified person is acceptable?
3. What is x-ray validity is acceptable for BA/BE Study? One year is acceptable if Ethics committee approving it.
Posting: # 18763
» 1. Is it acceptable regulatory point of view (AnVIsa, EMA), If we identify haemolysed samples with it's grade (severe, moderate, slightly) during sample receipt in bioanalytical lab instead of [...] at clinical stage during sample separation
I can't answer for ANVISA. On the European perspective: there is nothing about this in the EMA guideline.
But I would not put this only on a regulatory perspective. I would test it practically: is it easier to detect and grade haemolysis in thawed samples or frozen samples ? And does it not result in a delay in the proper storage of the samples once received ?
It may actually make sense to evaluate and record haemolysis after thawing the samples when you process them (unless you have bench top stability issues and have to process your samples quickly under specific conditions). One advantage: I have seen once a case where the first aliquot was haemolysed and the duplicate was not. The reason is that the plasma had not been separated properly and some red blood cells were aspirated and transferred into one of the tubes. The first aliquot had been processed and the red blood cells were lysed when thawed. The second aliquot had not been thawed and some RBC were visible at the bottom of the tube, if paying attention. This is not something you can easily see before freezing the samples, nor in frozen samples, but which becomes obvious once you thaw them.
» 3. What is x-ray validity is acceptable for BA/BE Study? One year is acceptable if Ethics committee approving it.
This is more of a medical and scientific discussion than regulatory. Once again I can't answer for ANVISA. EU: nothing in the EMA guideline. I would say it depends on the prevalence of TB in your region.