Bioequivalence and Bioavailability Forum • Strength selection

Strength selection [Design Issues]

posted by Paresh – 2012-01-27 07:47 (5249 d 16:56 ago) – Posting: # 8008
Views: 5,053

Dear all,

I have one question regarding strength selection?

If reference drug having list of strength 10mg, 20mg, 40mg, and 80mg.
I have developed all strength and need to conduct BE study on highest strength 80mg. But for reference can i select dose as 2x40mg=80 for BE study.
Due to un availability of reference drug as 80mg.

Thanks
Paresh

Complete thread:

Strength selectionParesh 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 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