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

posted by dshah  – India/United Kingdom, 2022-05-27 20:40 (634 d 06:15 ago) – Posting: # 23028
Views: 1,131

Dear janasari!
The link of PAR (Approved just before the Oct'18) is provided where the acceptance range is 80-120%. From guideline perspective, the 10% usually can be considered as CI.
Regards,
Divyen

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