Log in
Register|
govardhanpillari ☆ India, 2010-07-01 15:55 (5843 d 05:16 ago) Posting: # 5581 Views: 6,586 |
|
|
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 — Govardhan.P |
|
Marcel ★ 2011-04-15 12:10 (5555 d 09:01 ago) @ govardhanpillari Posting: # 6903 Views: 4,828 |
|
|
❝ 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 |
|
olacy ☆ Hungary, 2011-10-13 12:55 (5374 d 08:16 ago) @ Marcel Posting: # 7476 Views: 4,236 |
|
|
The Outlaw Torn ★ Europe, 2011-10-27 13:18 (5360 d 07:53 ago) @ olacy Posting: # 7552 Views: 4,301 |
|
|
Hi olacy, We too had the same concern as you and had heard the same rumors as voiced above, so we attended a pre-submission meeting with Affsaps and they requested a therapeutic equivalence study in patients with chronic kidney disease (5 week lead in with 8 week crossover design—the primary endpoint being phosphorus control and secondary endpoints being safety). The clinical assessor there didn't think this was necessary, but it was requested by the quality people in other countries. And since this is the advice that had already been given to other companies who had requested scientific advice, they felt they had to fall in line with those recommendation. Not good news, but I hope it's helpful. Good luck. |
Ing. Helmut Schütz