Bioequivalence and Bioavailability Forum • Dose proportionality and BE

Dose proportionality and BE [Design Issues]

posted by sciguy – Canada, 2011-11-02 17:52 (5345 d 02:52 ago) – Posting: # 7586
Views: 11,225

Hi all,

I'm new to the forum and just wanted to get opinions from the group on the following issue:
The sponsor wants to compare two different formulations of a drug with 2 different strengths, say 5 mg vs 10 mg. Dose normalization on the relevant PK parameters is performed and the assessment of equivalence using standard BE criteria is applied. If BE is met, we can only conclude dose proportionality but not bioequivalence since 2 different strengths are being compared. True bioequivalence must be evaluated on non dose-normalized data. Agree/disagree?

Thanks a lot!

sciguy

Complete thread:

Dose proportionality and BEsciguy 2011-11-02 16:52
- Dose proportionality and BE Helmut 2011-11-02 21:11
  - Dose proportionality and BE sciguy 2011-11-03 20:30
    - Dose proportionality and BE Helmut 2011-11-03 21:06
      - Dose proportionality and BE Ohlbe 2011-11-04 10:19
      - Dose proportionality and BE sciguy 2011-11-04 15:34
        
        Dose proportionality and BE Helmut 2011-11-04 16:25
        
        Dose proportionality and BE sciguy 2011-11-04 19:18
        
        Dose proportionality and BE Helmut 2011-11-04 19:55