Anand
☆    

India,
2014-09-24 15:22
(4297 d 20:15 ago)

Posting: # 13564
Views: 3,411
 

 US ANDA submitted to Health Canada / RLD selection [Regulatives / Guidelines]

Post reply
Dear All,

  1. Please clarify USFDA Filled ANDA product can be filled to Health Canada? Based on RLD Strength same in USA & Canada without doing BE study.

  2. US RLD product is not available in Canada, then how to select RLD in Canada for BE study?

Thanks in Advance

Regards,
Anand

Edit: Two posts merged; subject line adjusted to content. [Helmut]
 
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2014-09-24 15:55
(4297 d 19:42 ago)

@ Anand
Posting: # 13566
Views: 2,715
 

 Search!

Post reply
Hi Anand,
  1. With rare exceptions, no. In general the Canadian reference product has to be used. If you want to run only one study (instead of two cross-overs), perform a three-period study with the US RLD, the Canadian reference, and your test product.
  2. Please [image] search the forum first (see the Policy). You easily would have found this thread and the link to Canada’s Drug Product Database.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
 
Anand
☆    

India,
2014-09-25 08:15
(4297 d 03:22 ago)

@ Helmut
Posting: # 13575
Views: 2,693
 

 Search!

Post reply
Dear Helmut,

Thanks for your help.

Regards,
Anand
 
UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
234 visitors (0 registered, 234 guests [including 17 identified bots]).
Forum time: 11:38 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5