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Haemolysed sample identification in BA/BE study and others [Regulatives / Guidelines]

posted by vish14184 - India, 2018-05-09 17:43  - Posting: # 18759
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Dear all,

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.

Thank you

With regards
Vishal

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