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

posted by jansari – India, 2022-05-26 19:59 (80 d 13:41 ago) – Posting: # 23025
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Dear divyen,

Thank you very much for providing this supporting documents to justify the query..bt this PAR published in the year 2014 and 2017..so my concern is that whether we have to justify the response with this reference docs?

As EU release one guidance documents for locally acting drug in GI tract in oct 2018.this guidance is not as much clear as us fda guidance..

but in this guidance on page no. 10 stated that in vitro similarity should be assessed with +-10%acceptance limit..so similarity should be proven based on T/R ratio or 90%CI needs to b calculate?

Reference doc's attached with this post..


Kindly guide on this...

Thnk you in advance.....


Edit: Send by email to the forum address. @Jansari: Reply directly in the forum in the future. THX. [Helmut]

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