Bioequivalence and Bioavailability Forum • Dose proportionality and BE

Dose proportionality and BE [Design Issues]

posted by sciguy – Canada, 2011-11-04 20:18 (4977 d 04:32 ago) – Posting: # 7612
Views: 8,157

Hi Helmut,

❝ If you get a CI within 80–125% after 10 mg compare to 8 mg without dose-correction f is lower, right? It might be possible that (e.g. with an MR compared to an IR) you partly miss the absorption window of the drug. f will be lower.

You're right - I meant if f and clearance are different than it wouldn't be appropriate to dose normalize. In a properly designed study, it would seem unlikely clearance would be much different though since the strengths are similar.
Thanks for your input!

sciguy

Complete thread:

Dose proportionality and BE sciguy 2011-11-02 16:52 [Design Issues]
- 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 BEsciguy 2011-11-04 19:18
        
        Dose proportionality and BE Helmut 2011-11-04 19:55