Bioequivalence and Bioavailability Forum

Dear All,

Sevelamer carbonate is a non-absorbed phosphate binding cross linked polymer drug, which is not absorbed into the systemic circulation. Hence pharmacokinetic quantification is not possible for this molecule.

Generally, if PK quantification is not possible, pharmacodynamic study/small size clinical trial should be performed for generic submission. But, FDA recommends to do In-vitro phosphate binding equivalence and kinetic studies for generic submission.

My question is, whether EMEA will accepts the In-vitro phosphate binding studies for generic submission like US or need to do the pharmacodynamic studies for this molecule.

Thanks in advance for your help

Regards
PGR