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RegisterFampridine [Design Issues]
Hi MaggieSantos,
Not known.
You need a guess of your match (T/R) and your CV's. The latter can perhaps be guesstimated from this link.
Free? As in "free and unvalidated"? Do you mean Calculation of BE = calculation of confidence intervals or sample sizes or CV's? Or somehting else? At any rate forum.bebac.at is a good place to start for free services, ideas and pretty bad jokes.
I agree with Manteigas - you really need dialogue with regulators on this type of substance; the profile is tricky and easily leads to safety concerns. When safety (and convulsions) is a manifest issue as worded in the SPC then some regulators may automatically default to NTI thinking.
But also note that originator did some equivalence trials and from the wording of FDA's review indicates that 80.00%-125.00% was acceptable for (some of) those applications; this might be argumentation you could use in your future scientific advices or presub meetings with regulators?
Having said that, considering the safety profile of the drug and the fact that you sound like you are developing or testing your own new formulation I think you should go for a phase I / pilot where subjects are monitored a bit more intensely than usual, and then define the dual purpose as:
a. ensuring that your formulation is associated with a relevant safety profile
b. extracting relevant CV's that will allow you to do a sample size calculation for your own formulation.
Good luck.
❝ I would like to confirm two informations. Does Fampridine is considered a NTI drug for EMA?
Not known.
❝ Considering a CI limit of 90-111% whats the recomende sample size for fampridine.
You need a guess of your match (T/R) and your CV's. The latter can perhaps be guesstimated from this link.
❝ Do you know any good and free calculation site for BE?
Free? As in "free and unvalidated"? Do you mean Calculation of BE = calculation of confidence intervals or sample sizes or CV's? Or somehting else? At any rate forum.bebac.at is a good place to start for free services, ideas and pretty bad jokes.
I agree with Manteigas - you really need dialogue with regulators on this type of substance; the profile is tricky and easily leads to safety concerns. When safety (and convulsions) is a manifest issue as worded in the SPC then some regulators may automatically default to NTI thinking.
But also note that originator did some equivalence trials and from the wording of FDA's review indicates that 80.00%-125.00% was acceptable for (some of) those applications; this might be argumentation you could use in your future scientific advices or presub meetings with regulators?
Having said that, considering the safety profile of the drug and the fact that you sound like you are developing or testing your own new formulation I think you should go for a phase I / pilot where subjects are monitored a bit more intensely than usual, and then define the dual purpose as:
a. ensuring that your formulation is associated with a relevant safety profile
b. extracting relevant CV's that will allow you to do a sample size calculation for your own formulation.
Good luck.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Fampridine MaggieSantos 2017-09-20 13:05 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fampridine DavidManteigas 2017-09-26 10:55
- FampridineElMaestro 2017-09-26 11:23
Ing. Helmut Schütz