Sevelamer Carbonate In vitro binding study for EMA submission [Regulatives / Guidelines]

posted by jansari  – India, 2022-05-27 20:54 (756 d 17:40 ago) – Posting: # 23029
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Dear divyen,

We have already gone through this PAR.bt the same it's just before published guidance..so regulatory not accept this PAR..

And it's very difficult to pass the study in this acceptance range..it's very stringent range for sevelamer carbonate..and guidance doesn't provide any methodology like USFDA..

If you have any idea and submit sevelamer study in europe Market then please guide....

Thank you very much for your prompt reply and guidance...

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