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RegisterStrength to be evaluated for Canada submssion [Regulatives / Guidelines]
Dear All,
I gone through the both guidance of the Canada to find out on which strength the BE study should be performed. But i could not get any idea however there is clarity found about the strength to be use if drug does not follows linear kinetic.
Kindly advice, is it acceptable if i conduct study on highest strength for a drug which follows linear kinetic? or kindly suggest me any reference in which i can get such information.
Regards,
Compliance
I gone through the both guidance of the Canada to find out on which strength the BE study should be performed. But i could not get any idea however there is clarity found about the strength to be use if drug does not follows linear kinetic.
Kindly advice, is it acceptable if i conduct study on highest strength for a drug which follows linear kinetic? or kindly suggest me any reference in which i can get such information.
Regards,
Compliance
Complete thread:
- Strength to be evaluated for Canada submssionCompliance 2014-04-23 16:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Strength to be evaluated for Canada submssion Helmut 2014-04-24 06:20
- Strength to be evaluated for Canada submssion Compliance 2014-04-24 08:19
- Strength to be evaluated for Canada submssion Helmut 2014-04-24 06:20
Ing. Helmut Schütz