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RegisterRequired BE studies for sevelamer for EU [Regulatives / Guidelines]
❝ 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.
We are working on this same assumption, however some people internally are voicing concerns that some EU member states may require some type of clinical trial. However, this is pure speculation based on anonymous rumors. It doesn't appear to have any scientific merit, as far as I can tell. Should I hear anything else, I'll let you know.
Marcel
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- Required BE studies for sevelamer for EU govardhanpillari 2010-07-01 13:55
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Ing. Helmut Schütz