Bioanalysis Zone

How the origin of donors can influence the quantitation of a compound in plasma: case studies of matrix effect (inVentiv Health Clinical)



It is recommended in the guidelines for method validation that matrix effect from special population should be studied.

“If samples from special populations(such as renally or hepatically impaired populations) are to be analysed it is also recommended to study matrix effects using matrix from such populations.”

However, when studies are done in countries with different alimentary customs, should the matrix effect on that population be evaluated? Here in two case studies are described, demonstrating the influence of the origin of donors on bioanalysis of testosterone,eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

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