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Dear Forum,
Greetings..
We intend to file paediatric dosage forms (tablets) for ANDA
submission. Can anybody focus light on population required for
conducting BE study and/or relavent references?
Thanks in advance,
Chanukya
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Hi Chanukya,
In the past, we have done studies on suspensions that were to be used
by pediatric population. We conducted ANDA on healthy adults, and in
adult doses (take for example ped. dose is 5 ml, adult equivalent is
15 ml, hence you conduct the trial on adults dosing then 15 ml of
suspension). As for the references, use the FDA monograph/SPC - as per
the region of submission. Hope this helps.
--
Dr. Gagandeep Singh
Sr. Consultant,
Solutions Consulting Group
Cognizant Tech. Solns.
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