Bioequivalence and Bioavailability Forum

Submission in USA & Canada [Regulatives / Guidelines]

posted by luvblooms  – India, 2013-07-08 08:06 (4735 d 03:22 ago) – Posting: # 10961
Views: 7,090

Dear Jag and Others

Good Morning

I have an experience with one derma product where the clinical studies (PK and PD both) has been done using US innovator product and the same was submitted to Health Canada (along with the tests and data showing that both the reference i.e. US and Canada are same).

After a few basic question on the testing methodology and few suggestions the product got approved!


So yes, there is a risk but it could be done.


Hope this will help

Regards

Complete thread:

• Submission in USA & Canada Compliance 2013-07-05 13:29 
  • 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 reference jag009 2013-07-06 23:29
          • Non-Canadian reference Helmut 2013-07-07 13:49
    • Canadian reference jag009 2013-07-07 01:26
      • North American POVs / posting statistics Helmut 2013-07-07 14:49
  • Submission in USA & Canada jag009 2013-07-06 23:22
    • Submission in USA & Canadaluvblooms 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