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Dear All
Greeting for a day
We carried out the pharmacokinetic study of calcium channel blocker in male and female rat. The PK profile found to be very much differentiating.
Following are the some observation
PK parameter Male Female
Cmax(ng/mL) 200.42+/-75.1 901.40+/-82.80
tmax(h) 1 0.5
tlast(h) 4 12
Specifically the much difference is observed in tlast in male and female rat.
Is difference (tlast ) is acceptable?
Which one is the good model to perform the pharmacokinetic drug interaction studies(Male or female rat )?
Kindly give you valuable suggestion
Thanking you
NIL
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Using a conservative risk assessment profiling (unless there are marked differences in your test compound metabolism) based on exposure, I would suggest running DDI in the females as the exposure is higher. Have you confirmed anything in vitro with gender specific differences and does this translate to humans in vitro?
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The following message was posted to: PharmPK
Is this Wistar-rat? You will find higher CYP3A$ equivalent in male compared
to female, this should be seen in RLM assays comparing the gender
Best regards
Dirk
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