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RegisterNon-Canadian reference [Regulatives / Guidelines]
Hi Helmut!
Personally I think there is too much risk and time involved (what if you submit and they ultimately refuse). I rather spend some cash (for the extra arm) and run a three arm study to compare against references from both countries. This is assuming that you know the reference products from both countries are the same. Helmut, guru, correct me if I am wrong on this example ⇒ Procardia XL (USA) vs Adalat XL (CAN). I think they are the same product.
Note that Canadian ANDA requires potency correction BE analysis as well, US does not (but require potency difference between T and R to be within 5%).
John
❝ I have to modify my original response of “no way”. Actually there are some exceptions acceptable. See Canadian Reference Product ❝ Background.
❝ If all applicable criteria are fulfilled, a foreign reference product may be used in a BE study for generic filing.
Personally I think there is too much risk and time involved (what if you submit and they ultimately refuse). I rather spend some cash (for the extra arm) and run a three arm study to compare against references from both countries. This is assuming that you know the reference products from both countries are the same. Helmut, guru, correct me if I am wrong on this example ⇒ Procardia XL (USA) vs Adalat XL (CAN). I think they are the same product.
Note that Canadian ANDA requires potency correction BE analysis as well, US does not (but require potency difference between T and R to be within 5%).
John
Complete thread:
- Submission in USA & Canada Compliance 2013-07-05 13:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Canadian reference Helmut 2013-07-05 14:15
- Canadian reference Compliance 2013-07-06 06:32
- Non-Canadian reference Helmut 2013-07-06 15:20
- Non-Canadian referencejag009 2013-07-06 23:29
- Non-Canadian reference Helmut 2013-07-07 13:49
- Non-Canadian referencejag009 2013-07-06 23:29
- Non-Canadian reference Helmut 2013-07-06 15:20
- Canadian reference jag009 2013-07-07 01:26
- North American POVs / posting statistics Helmut 2013-07-07 14:49
- Canadian reference Compliance 2013-07-06 06:32
- Submission in USA & Canada jag009 2013-07-06 23:22
- Submission in USA & Canada luvblooms 2013-07-08 06:06
- Submission in USA & Canada Compliance 2013-07-08 09:01
- Submission in USA & Canada jag009 2013-07-08 15:12
- Submission in USA & Canada luvblooms 2013-07-08 06:06
- Canadian reference Helmut 2013-07-05 14:15
Ing. Helmut Schütz