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Dear Colleagues
We are working on a new dosage form (oral tablets) for a marketed
anticancer drug (marketed as an injection). There is a published data
for this drug injected form, there is also clinical data for the drug
in oral solution form in humans. Do we need to perform new animal
studies using the tablet or would the oral solution data be enough?
Please if you have a reference guideline for your answer it will be
highly appreciated.
Best Regards
Isra' Admour, M.Sc. Pharm
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Hi,Isra' Admour,
You'd better perform animal studies for the new dosage form.
It's not proper to evaluate the pk behavior of the drug, even you had
the data of injected form and studied its dissolution.
Yours
Jiang
2008.02.15.
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You have to run new studies with new oral formulation specially if the
drug falls out of BCS class I. Even then you might still need new data
that, it would be hard to justify the new oral formulation's PK to be
similar to solution.
Neil
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I think you have to go for in- vivo bio-equivalence studies of your
tablet and compare the bio-availability with your oral solution and
injection dates .
Thanks
Parvish kumar Sanehi
M.Pharm
IISc, Bangalore
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