Chromatography Forum

Hi,

I've a, maybe very basic, question..... but I would be sure about it!!
Here it is:

If I have a method LC-MSMS validated in SERUM matrix....
... and now I have to analyse samples in PLASMA.....

Can I use this method?

I now that the validation has to be done in the same matrix to be analysed.
But in the case I couldn't analysed my plasma samples, could I process some Quality Control samples prepared in plasma and check them as a way to validate the method in plasma?

Please, could you help me?

Thank you very much!!

Do you work under a regulating body? If do that may limit the answer. If you do not work under a regulating body, who sets guidance for your method validation? If it is up to you, then can you use QC material and demonstrate accuracy, precision, etc. of your method?

Hi,

The validation is up to me.
And following the "European Guideline", it says that a Partial Validation can be done when:

Changes for which a partial validation may be needed include transfer of the bioanalytical method to another laboratory, change in equipment, calibration concentration range, limited sample volume, another matrix or species, change in anticoagulant, sample processing procedure, storage conditions etc. All modifications should be reported and the scope of revalidation or partial validation justified.

and also the "FDA Guideline" justify a Partial Validation when:

· Bioanalytical method transfers between laboratories or analysts
· Change in analytical methodology (e.g., change in detection systems)
· Change in anticoagulant in harvesting biological fluid
· Change in matrix within species (e.g., human plasma to human urine)
· Change in sample processing procedures
· Change in species within matrix (e.g., rat plasma to mouse plasma)
· Change in relevant concentration range
· Changes in instruments and/or software platforms
· Limited sample volume (e.g., pediatric study)

Can anybody explain me some individual experience?

Thank you very much