Bioequivalence and Bioavailability Forum • European BE study for Canada?

Dr_Dan
★★

Germany,
2012-05-29 11:56
(5145 d 00:09 ago)

Posting: # 8623
Views: 3,174

European BE study for Canada? [Regulatives / Guidelines]

Dear all
We conducted an open label BE study with our test product against the European innovator product. Would it be possible to submit this study to get a marketing authorization in Canada?
I see two problems:
a) The study was not blinded (see 2.4.2 of the Canadian BE guideline), but I think there are good arguments against this demand
b) The reference product was the European innovator product but this is also marketed in Canada.
Has anyone experience with this situation? I am unable to find C.08.004 in the Food and Drug Regulations (C.R.C., c. 870) http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/page-288.html#h-297
I am looking forward to your advice.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

jag009
★★★

NJ,
2012-05-30 20:13
(5143 d 15:53 ago)

@ Dr_Dan
Posting: # 8633
Views: 2,516

European BE study for Canada?

Post reply

Hi Dr. Dan,

1) I don't think TPD (Canada) will enforce the blinded issue. We submitted US FDA open-label studies (BE and NDA) for Canadian filing and they were okay.
2) Are the names of the innovator product (Euro and Canada) the same?

John

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Vijaya
☆

India,
2012-06-01 12:44
(5141 d 23:22 ago)

@ Dr_Dan
Posting: # 8648
Views: 2,447

European BE study for Canada?

Post reply

❝ ❝ Has anyone experience with this situation? I am unable to find C.08.004 in the Food and Drug Regulations (C.R.C., c. 870) http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/page-288.html#h-297

❝ I am looking forward to your advice.

❝ Kind regards

❝ Dan

Greetings to all !

Dear Dr.Dan,

C.08.004 can be found in page no.: 1036 in C.R.C.,c.870

Hope it helps.

Regards,
Vijaya.

Dr_Dan ★★ Germany, 2012-06-01 14:19 (5141 d 21:47 ago) @ Vijaya Posting: # 8650 Views: 2,428	European BE study for Canada? Post reply
	Yes, you are right. I really need new glasses.... — Kind regards and have a nice day Dr_Dan