Bioequivalence and Bioavailability Forum • Strength selection

Strength selection [Design Issues]

posted by Paresh – 2012-01-28 12:29 (5248 d 20:51 ago) – Posting: # 8010
Views: 4,559

❝ Which regulation? In the US there is only one RLD – generally the highest strength. Was the 80mg strength discontinued? If yes, why? We need more information.

Dear,

It is for EUROPE submission. 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.

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Complete thread:

Strength selection Paresh 2012-01-27 06:47 [Design Issues]
- Strength selection Helmut 2012-01-27 16:07
  - Strength selectionParesh 2012-01-28 11:29
    - Strength selection Helmut 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