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Samaya B ☆ India, 2014-06-28 09:18 (4383 d 18:52 ago) Posting: # 13162 Views: 5,404 |
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Dear All, Good morning!! As per Summary of Product Charactristics (SPC), Fampyra 10 mg prolonged-release tablets is a narrow therapeutic Index drug. http://www.medicines.org.uk/emc/medicine/25003/SPC/Fampyra+10+mg+prolonged-release+tablets/#PHARMACOKINETIC_PROPS USFDA dose not consider Dalfampridine Extended Release Tablets 10 mg as a NTI. Do we have to follow 90.00 - 111.11% CI limit for AUC in case of EU submission?? Kindly advice. Thanks. Regards, Samaya. |
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ElMaestro ★★★ Denmark, 2014-06-28 13:16 (4383 d 14:55 ago) @ Samaya B Posting: # 13164 Views: 4,476 |
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Hello Samaya B, ❝ Do we have to follow 90.00 - 111.11% CI limit for AUC in case of EU submission?? That is a very good question. One one hand, the SPC says it is an NTI drug and the guideline says: "In specific cases of products with a narrow therapeutic index, the acceptance interval for AUC should be tightened to 90.00-111.11%." On the other hand, the innovator used a BE study with conventional limits in the development of Fampyra, and this was accepted by regulators. See page 23 og the assessment report here. What's the verdict then? If you have ample time get a scientific advice and use the above info to argue that 80.00%-125.00% should apply in your study. Then do what you are told. Otherwise, play it safe and use 90.00% to 111.11%. — Pass or fail! ElMaestro |
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Samaya B ☆ India, 2014-06-30 08:50 (4381 d 19:20 ago) @ ElMaestro Posting: # 13167 Views: 4,483 |
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Dear ElMaestro, Thank you so much for the responce. We will go ahead to get scientific advice from EMEA. Regards, Samaya. |
Ing. Helmut Schütz