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I am working on estimation of a female steroidal hormone in plasma for a given dose. I developed and validated LCMSMS method in human (Male) plasma.
1) Is there any guideline which suggest i have to do cross validation / partial validation in blank female plasma.
OR i can go ahead with a developed method for human male plasma, while plasma samples were collected from female plasma after dosing.
2) Is there any impact in estimation of female hormones in plasma having the male hormones.
3) As the species is same but hormonal differences are there, may impact on the results.
Expert comments are invited...
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The following message was posted to: PharmPK
I am assuming that you analyzing human plasma. If you are planning to dose
the female hormone in males you could use your method developed in male
plasma. But if the hormone is being given to females then you should use
female plasma to validate the assay. Interferences (due to matrix
differences) may crop up when you analyze the real samples which may
jeopardize your study. If females are being used in the study, you will
encounter a certain level of that hormone in your blanks (pre-dose) samples
which is often called as baseline value because the hormone is endogenous to
females. That is why you may have to collect several blood samples prior to
dosing (e.g. -10 hr, -6 hr, -2hr, -1 hr -0.5 hr , 0 hr) to determine the
average baseline value of that subject which is then subtracted from the
single value obtained for a non-zero plasma sample. Keep in mind that if
there is circadian rhythm involved then the sampling should take account of
Hope this helps.
Manish Issar, Ph.D
Applied Biopharmaceutics, LLC
2010 Cascade Drive
Corona, CA 92879
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