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The following message was posted to: PharmPK
Dear All
I am developing the new formulation via nasal route. We want to do
the preclinical study. How dose optimization has to be carry out? Is
it totally based on the toxicity study data of different dose?
If want to compare the bioavailability with oral dosage form, same
amount of dose can be administered via nasal route as like oral in
animal models, is it possible?
If anyone can provide the reference it will be good?
Suggestion will be appreciated
Thanking you
PRASHANT
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The following message was posted to: PharmPK
Dear Prashant,
First of all your pharmacology team should have selected dose and
concentration for the nasal route, if not then they should conduct a MTD
for that particular route to check the tolerance of compound and vehicle
by this route. The doses should not be based on the toxicity data but
based on the efficacy study data the dose for toxicity study will be
selected later. Here again I would like to repeat one thing that based
on MTD study you can select the dose for comparison of Bioavailability
in Nasal Vs Oral, If you MTD dose in nasal is less then your oral dose
then you have to try the study on MTD dose only and if it is higher then
your oral dose then there is no problem to go with oral dose.
This all is based on my knowledge and experience, right now I don't have
any literature but I will provide in future if possible.
You can ask more on this if you need
Thanx & Regards
Chintan Patel
Pharmacology & Toxicology
Cadila Pharmaceuticals Limited
1389, Trasad Road
Dholka - 387 810
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