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Dear all,
I am very much thankful if some one explain or clarify about the
following query
Please clarify about the percentage of Clinical Samples that can be
repeated during analysis.
Regards
Abirami
QA
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Dear Abirami,
No guidelines except ANVISA mentions the percentage of Clinical
Samples that can be repeated during analysis. As per ANVISA only 20 %
of samples can be repeated.
Dr. Mandar Mote
Manager Bio-analytical
Bio-equivalence
Macleods Pharmaceuticals Ltd.
Mumbai
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Dear Abirami,
I think your question is not very clear. As per my understanding goes
there is no fixed percentage of clinical samples which can be repeated.
The decision to reanalyze the clinical samples should be SOP driven
and if any of the samples are failing this predefined criteria (like
peak shape, peak area, internal standard variation, bad
chromatography, above calibration range etc., ), then all these
samples need to be reanalyzed.
Hope this makes things clear.
Comments from the experts are welcomed
Regards
Dr. Tausif Ahmed
Ranbaxy Research Laboratories
India
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