Bioequivalence and Bioavailability Forum • Non-Canadian reference

Non-Canadian reference [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-07-06 17:20 (4738 d 08:08 ago) – Posting: # 10953
Views: 7,262

Hi Compliance,

❝ I think you are getting irritated and I am sorry for that.

I was; already forgotten.

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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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

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 referenceHelmut 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 & 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