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RegisterFampyra 10 mg prolonged-release tablets NTI [Regulatives / Guidelines]
Hello Samaya B,
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%.
❝ 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
Pass or fail!
ElMaestro
Complete thread:
- Fampyra 10 mg prolonged-release tablets NTI Samaya B 2014-06-28 07:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fampyra 10 mg prolonged-release tablets NTIElMaestro 2014-06-28 11:16
- Fampyra 10 mg prolonged-release tablets NTI Samaya B 2014-06-30 06:50
- Fampyra 10 mg prolonged-release tablets NTIElMaestro 2014-06-28 11:16
Ing. Helmut Schütz