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I have a specific queries regarding method validation. If I have
validated method on API 3000 and subject sample analsis carried out on
API-4000. which excercise needs to be performed under partial
validation?
Regards
Kinjal
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The following message was posted to: PharmPK
Three accuracy and precision runs which include the LLOQ and ULOQ as
well as the three QCs and blank matrices- as well as carryover exam
should do it
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The following message was posted to: PharmPK
Dear kinjal Joshi,
If you are changing the instrument then in that case you have to
perform the minium two precision and accuracy batchs, Selectivity,
matrix effect, recovery and carryover experiment.
Hope this will help you.
Regards
laxman kaswan
LifeSan Clinical Research
Mumbai
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Dear Kinjal,
As the two mentioned instruments differ in sensitivity; you need
to perform the experiments which include sensitivity as a acceptance
criterion i.e.
1. Sensitivity - In my opinion it will not be affected as you have
performed analysis on higher spec, but still need to have some data in
hand to support your statement.
2. Selectivity - As the signal for lower limit (also the matrix
factors), will be higher you need to prove the selectivity and matrix
effect both.
3. Linearity range- Due to sensitivity enhancement the range proved on
API3000 may not be linear for API4000.
4. Stability- Need not to be performed if your previous linearity
range is not affected.
5. Precision- same as stability.
Hope it helps,
Regards
Kuldeep Sharma
DMPK-Jubilant Biosys
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Dear Kinjal-
Regarding Partial Validation when switching instruments as indicated
in your message, I agree with Ed O'Connor's recommendation. I would
also recheck a calibration curve equation with results from an
analysis run to either confirm the same regression and weighting
scheme on the more sensitive instrument, or indicate a different one.
I would also consider checking matrix effect.
-Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development / Analytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.aaa.elan.com
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The following message was posted to: PharmPK
Hi Kinjal,
First of all I will not suggest you to perform subject sample analysis
in API 4000 but if you are keen to perform the same in API 4000, I
will prefer to do the following experiments, as all these experiments
are instrument dependent. You can perform other experiments which are
instrument dependent also.
System Suitability, Selectivity and sensitivity, P& A Batches, Ion
Suppression/enhancement, Reinjection reproducibility. I will recommend
you to perform carry over test also.
But I have seen people start their analysis after conducting only
selectivity and Full P& A Batches (With LLOQ).
Regards,
Sudipta Basu
Senior Research Scientist (DMPK)
E-Mail : sudipta.b.-at-.saiadvantium.com
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Hi Kinjal,
According to me when your going to the higher version there will not
be any problem on the sample analysis. since the sentivity and other
things are higher then the API3000. So, want you need to do is prform
Precision & accuracy on API 4000 and validate it.
regds,
Venkatesan
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