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RegisterFasting or Fed condition (Canada) [Design Issues]
Hello!
It's been a while since my last query...so here I am again!
We would like to conduct a BE study in order to file our product in Canada, but we face a dilemma in the BE design. According to the already approved PIL of the Canadian reference product, the drug should be taken by mouth during a meal and with a large glass of water, while in the SmPC it is clearly stated that there are no clinically relevant differences in absorption when the reference product was administered either with food or in the fasting state. Keeping in mind that the Canadian Health Authority recommends BE studies under fed conditions only for specific categories of products (Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (2005)), we were of the opinion of conducting a BE study under fasting condition, while our Canadian CRO was of the opposite opinion. So, can you please share with us your point of view on the design?
Thank you in advance for your assistance!
Edit: Subject line extended, document linked. [Helmut]
It's been a while since my last query...so here I am again!
We would like to conduct a BE study in order to file our product in Canada, but we face a dilemma in the BE design. According to the already approved PIL of the Canadian reference product, the drug should be taken by mouth during a meal and with a large glass of water, while in the SmPC it is clearly stated that there are no clinically relevant differences in absorption when the reference product was administered either with food or in the fasting state. Keeping in mind that the Canadian Health Authority recommends BE studies under fed conditions only for specific categories of products (Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (2005)), we were of the opinion of conducting a BE study under fasting condition, while our Canadian CRO was of the opposite opinion. So, can you please share with us your point of view on the design?
Thank you in advance for your assistance!
Edit: Subject line extended, document linked. [Helmut]
Complete thread:
- Fasting or Fed condition (Canada)ElMag 2012-02-22 16:23 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fasting or Fed condition (Canada) drgunasakaran1 2012-02-22 16:56
Ing. Helmut Schütz