Bioequivalence and Bioavailability Forum • Strength selection

Strength selection [Design Issues]

posted by Helmut – Vienna, Austria, 2012-01-28 15:27 (5249 d 00:47 ago) – Posting: # 8011
Views: 4,364

Dear Paresh!

❝ It is for EUROPE submission.

I’m not deaf. No need to shout.

❝ One client ask that the highest strength generally not in market. So for the same they need to conduct study as test 80mg and 2x40mg reference for BE.

‘Generally’ is not enough. The 80mg reference must not be on the market in any country of the EU, Norway, Switzerland,… Otherwise this reference must be used.
It should be possible to test 80mg vs. 2×40mg if the 80mg dose (!) of the reference is approved.
If the the 80mg dose is not approved, you are discovering a new area: BE + clinical study; hopefully you may use the tox data, etc.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

Strength selection Paresh 2012-01-27 06:47 [Design Issues]
- Strength selection Helmut 2012-01-27 16:07
  - Strength selection Paresh 2012-01-28 11:29
    - Strength selectionHelmut 2012-01-28 14:27
      - Strength selection Ohlbe 2012-01-28 18:20
        
        Swiss reference? Helmut 2012-01-28 18:30
        
        Swiss reference? Ohlbe 2012-01-28 22:31
        
        EU reference! Helmut 2012-01-29 03:51