Bioequivalence and Bioavailability Forum • Strength selection

Strength selection [Design Issues]

posted by Ohlbe – France, 2012-01-28 19:20 (5248 d 17:43 ago) – Posting: # 8012
Views: 4,348

Dear Helmut and Paresh,

❝ The 80mg reference must not be on the market in any country of the EU, Norway, Switzerland,… Otherwise this reference must be used.

AFAIK products from Switzerland will not be accepted as reference in the EU (no exchange of information: EU Agencies cannot be sure the composition and manufacturing process of the Swiss product are the same as for the EU product).

Regards
Ohlbe

—
Regards
Ohlbe

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 selection Helmut 2012-01-28 14:27
      - Strength selectionOhlbe 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