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RegisterNDA study for Mexico [Regulatives / Guidelines]
Hi,
Does anyone have experience conducting NDA studies for ER products in Mexico? I mean running a study comparing ER once a day vs IR given multi-times a days, e.g, ER vs IR given every 4 hours. When conducting such studies, the success criteria is based on equivalent AUC (90% CI), and not Cmax due to the nature of the ER drug release kinetic.
I received a comment from the mexico regulatory when they reviewed the protocol. They wanted Cmax as an equivalent criteria as well but that is not my intention (I ran studies like this in US and usually this is not a problem at the protocol review stage).
Thx
J
Does anyone have experience conducting NDA studies for ER products in Mexico? I mean running a study comparing ER once a day vs IR given multi-times a days, e.g, ER vs IR given every 4 hours. When conducting such studies, the success criteria is based on equivalent AUC (90% CI), and not Cmax due to the nature of the ER drug release kinetic.
I received a comment from the mexico regulatory when they reviewed the protocol. They wanted Cmax as an equivalent criteria as well but that is not my intention (I ran studies like this in US and usually this is not a problem at the protocol review stage).
Thx
J
Complete thread:
- NDA study for Mexicojag009 2019-12-06 16:19 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Cmax ER = Cmax IR ? Helmut 2019-12-06 16:41
- Cmax ER = Cmax IR - the only option mittyri 2019-12-06 17:08
- Cmax ER = Cmax IR - the only option Helmut 2019-12-06 17:36
- Cmax ER = Cmax IR ? jag009 2019-12-06 17:38
- Cmax ER = Cmax IR ? Helmut 2019-12-06 17:45
- Cmax ER = Cmax IR ? jag009 2019-12-06 21:21
- Cmax ER = Cmax IR ? Yura 2019-12-06 22:40
- Cmax ER = Cmax IR ? jag009 2019-12-09 18:15
- Cmax ER = Cmax IR ? Yura 2019-12-06 22:40
- Cmax ER = Cmax IR ? jag009 2019-12-06 21:21
- Cmax ER = Cmax IR ? Helmut 2019-12-06 17:45
- Cmax ER = Cmax IR - the only option mittyri 2019-12-06 17:08
- Cmax ER = Cmax IR ? Helmut 2019-12-06 16:41
Ing. Helmut Schütz