Hi Everyone!
I'm hoping you can help me find out where to look for a reliable source to cite to support the acceptability of the excipients we are using in our formulation - as part of our Pediatric Study Plan to be submitted to FDA. I am specifically looking for the safe levels that can be used in pediatric oral formulations. I have looked in many places and have some vague references I can probably cite - but I am now wondering if there is a central repository for this sort of information that I'm not aware of. Or is there a tried and tested way to provide support for the choice of excipients within the PSP?
Any pointers would be gratefully received! :)
Many Thanks
Sue
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Susan Evans MBA
Manager Regulatory Affairs
Aurinia Pharmaceuticals Inc.
Victoria BC
Canada
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