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The following message was posted to: PharmPK
Dear Sir,
I have to carry out a study of subacute toxicity in
rabits for a product that will be administered
intravaginally.
I have no references about the LD50 of the active
drugs by this route.
Moreover, I have a limit of volume that the animal can
recieve and also the drug solubility (the product is
already a suspension)
I have to give three different doses (to three
different groups of animals and a control group with
vehicle), how can I choose them? If I consider the
dose in mg/kg for woman and convert it to the rabbit,
I think that the smallest dose should be 3 times that
for human. For the following doses, should I prepare
another formulation more concentrated or just
administer more product? Because if I prepare a new
formulation it may not have the same bioavailabilty as
the original product but perhaps with the highest dose
determine by the greater volume the animal allows will
not induce toxicity.
Thanks everybody,
Paula Schaiquevich
ININFA-CONICET
Buenos Aires, Argentina
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