Bioequivalence and Bioavailability Forum

Dose proportionality and BE [Design Issues]

posted by Helmut  – Vienna, Austria, 2011-11-04 20:55 (4930 d 07:48 ago) – Posting: # 7613
Views: 7,876

Hi sciguy!

❝ 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.

Yes, that’s the second assumption in BE-testing: identical clearances. In the good ol’ days this assumption seemed to be justified. But we have learned from Les Benet that this must not necessarily always be the case. Different excipients may play havoc with transporters. But how do we calculate clearance? CL=D×F/AUC. Back to the unknows. The only way out of this dilemma would be simultaneous administration of a stable isotope-labeled API. As a nice side effect HVDs would disappear, leaving only HVDPs for scaling.

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Helmut Schütz


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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 BE sciguy 2011-11-04 19:18
              • Dose proportionality and BEHelmut 2011-11-04 19:55