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Dear Sudipta Sir,
Thanks for your reply,
I have one more query
If we develop the method in LC/MS/MS for any drug and validate it in control matrix (e.g. in Human Plasma in India), now if we got study samples from abroad (outside of India).
My question is " Is there any need to perform one Precision & Accuracy Batch in same matrix from which clinical samples collected?",
If not than why?
Kanchan Soni
Sr. Research Associate-Bio Analytical
Veeda Clinical Research
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The following message was posted to: PharmPK
Hi Kanchan,
In the validation experiments, I'm sure that you must have done specificity/ selectivity experiment using minimum 6 different lots of blank plasma, if that exp. meets the acceptance criteria then no need to perform P& A batch again.
Please check the type of anticoagulant in the clinical samples. If anticoagulant is different, need to perform an anticoagulant P&A batch.
To play safe, my advice is to perform one P&A batch in the clinical (Abroad) matrix, as it will also give you an idea about the matrix effect.
Regards,
Sudipto Basu
Senior Research Scientist (DMPK & Tox)
Sai Advantium Pharma Ltd.,
E-Mail : sudipta.b.at.saiadvantium.com
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Dear Sudipta,
How P&A can give idea abut matrix effect ??
Regards,
Bhavesh
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The following message was posted to: PharmPK
Dear Bhavesh,
Yes, your question is valid to some extend. For matrix effect you have to perform qualitative and quantitative experiements during validation. From these two experiments only you will get some idea about matrix effect. Some time those exp are not sufficient to measure matrix effect. That's why after successful completion of validation we observed batch fail during actual sample analysis (Some time other factors like processing error also plays role). Most of the time that is because of matrix effect because of huge intra subject matrix population. During validation we have tested few.
As the clinical samples are from different race (New Matrix), their matrix may be different from the validated matrix. Which may affect the analysis. Causing problems like late eluting peak, adjucent peak, creating problem in QCs (Batch acceptance criteria), same m/z etc. Hence what I meant to say about matrix effect is in broader sense not just matrix effect quantification.
I hope I clarifiy my concern.
Regards,
Sudipta Basu
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kanchan,
Rather than going for P A batch, 1st you go for matrix effect , as the samples are of different species; I mean to say, foreign plasma is different from Indian plasma due to their different appetite, food style and diet patterns, there are chances of endogeneuos materials interfering in matrix. Also, you will come to know the extraction pattern for the same during sample processing. I hope this suffices your question.
Shital P.
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