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RegisterSevelamer Carbonate In vitro binding study for EMA submission [Regulatives / Guidelines]
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
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
Complete thread:
- Sevelamer Carbonate In vitro binding study for EMA submission jansari 2021-09-24 19:03 [Regulatives / Guidelines]
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Ing. Helmut Schütz