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

posted by jansari  – India, 2021-09-24 21:03 (930 d 20:22 ago) – Posting: # 22597
Views: 2,286

Dear All,

As I am working in In vitro laboratory. And we are doing In-vitro binding study on Sevelamer carbonate sachets for EMA submission.


My question is, whether EMA will accepts the In-vitro phosphate binding studies for generic submission like US. Is there any specific guidance documents for statistical analysis of Sevelamer carbonate for EMA Submission or can we perform statistical analysis as per USFDA guidance documents?

And if we perform statistical analysis as per USFDA guidance documents(Acceptance limit for K2-80% to 120%) is it acceptable for EU submission? Is there any acceptance limit for Sevelamer carbonate product for EMA submission?

A response will be highly appreciated.

Thanks in advance for your help.


Regards,
APJ

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