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RegisterNaproxen ER FDA guidance [Regulatives / Guidelines]
Hi all,
I was looking at the FDA guidance for Naproxen ER tablet:
Naproxen ER FDA guidance
It says: "Additional Comments: This drug product is designed to provide both a quick onset and prolonged action. Please ensure that the Tmax (time to peak plasma naproxen concentrations) is comparable between the test and reference products."
What does "comparable" mean? Is this a qualitative comparison or an important criterium that needs to be statistically analysed? If so, what would be the best way to do this?
One way would be to do partial AUCs, for example AUC0-Tmax and AUCTmax-t and have those pass the 80-125 criterium. Is this necessary?
Thanks,
Mac
I was looking at the FDA guidance for Naproxen ER tablet:
Naproxen ER FDA guidance
It says: "Additional Comments: This drug product is designed to provide both a quick onset and prolonged action. Please ensure that the Tmax (time to peak plasma naproxen concentrations) is comparable between the test and reference products."
What does "comparable" mean? Is this a qualitative comparison or an important criterium that needs to be statistically analysed? If so, what would be the best way to do this?
One way would be to do partial AUCs, for example AUC0-Tmax and AUCTmax-t and have those pass the 80-125 criterium. Is this necessary?
Thanks,
Mac
Complete thread:
- Naproxen ER FDA guidancelechia 2014-04-14 22:57 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Naproxen ER FDA guidance Helmut 2014-04-15 13:09
- Naproxen ER FDA guidance jag009 2014-04-15 15:36
- Naproxen ER FDA guidance lechia 2014-04-15 16:10
- Naproxen ER FDA guidance lechia 2014-04-24 16:49
- Naproxen ER FDA guidance sunny 2014-04-25 02:43
- Naproxen ER FDA guidance lechia 2014-04-24 16:49
- Naproxen ER FDA guidance sunny 2014-04-17 00:07
- Naproxen ER FDA guidance Helmut 2014-04-15 13:09
Ing. Helmut Schütz