In vitro binding study for sevelamer carbonate for Europe submission [Regulatives / Guidelines]

posted by jansari  – India, 2023-02-23 17:22 (422 d 03:04 ago) – Posting: # 23472
Views: 1,925

Dear Divyen,
Thank you very much for your kind support..but still I want some clarity.

❝ Kindly refer your own post Sevelamer Carbonate In vitro binding study for EMA submission (Post#22597).

yes it's my Post..but still not getting any clearity about this...all PAR and guidance documents are available as per USFDA Europe guidance is different for sevelamer carbonate..and they didn't accept USFDA guidance documents.. regulatory didn't accept our study which we were performed based on USFDA guidance we have to perform the same study again as per Europe guidance before starting the study i want to clear about the acceptance limit.

❝ Kindly refer Renvela CHMP ASSESSMENT REPORT

they given the reference of following of guidance documents of Europe:: Guideline for locally applied , locally acting product in Gestrointestinal trac(CPMP/EWP/239/95Rev.1,Cor.1*) and this guidance documents given the acceptance limit as +- 10percentage..

The CHMP assessment which you have shared is also published in the year 2009..

Thanks in advance....


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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