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RegisterNo Food effect on NDA (505(b)1 or 2) [Regulatives / Guidelines]
Hi all,
Question for NDAs (FDA or EMA)... If you want to claim no food effect on your new product, is it base on the 90% CI for Cmax and AUCs from a food effect study? I had a previous submission with a product having Fed/Fasting Cmax ratio of 1.22 but the 90% CI was beyond 80-125% (AUC was fine on both Ratio and 90%CI) and FDA granted us no food effect. I asked people about this and they said one needs to pass the 90% CI in order to declare no food effect...
Thanks
John
Question for NDAs (FDA or EMA)... If you want to claim no food effect on your new product, is it base on the 90% CI for Cmax and AUCs from a food effect study? I had a previous submission with a product having Fed/Fasting Cmax ratio of 1.22 but the 90% CI was beyond 80-125% (AUC was fine on both Ratio and 90%CI) and FDA granted us no food effect. I asked people about this and they said one needs to pass the 90% CI in order to declare no food effect...
Thanks
John
Complete thread:
- No Food effect on NDA (505(b)1 or 2)jag009 2015-03-19 16:16 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No Food effect on NDA (505(b)1 or 2) krish85 2015-03-24 05:44
- No Food effect on NDA (505(b)1 or 2) luvblooms 2015-03-24 10:06
- No Food effect on NDA (505(b)1 or 2) Helmut 2015-03-24 10:39
- No Food effect on NDA (505(b)1 or 2) luvblooms 2015-03-24 11:08
- No Food effect on NDA (505(b)1 or 2) Helmut 2015-03-24 10:39
- No Food effect on NDA (505(b)1 or 2) luvblooms 2015-03-24 10:06
- No Food effect on NDA (505(b)1 or 2) krish85 2015-03-24 05:44
Ing. Helmut Schütz