Bioequivalence and Bioavailability Forum • DDI only in steady state

DDI only in steady state [Design Issues]

posted by Helmut – Vienna, Austria, 2014-12-08 19:30 (4221 d 01:06 ago) – Posting: # 14021
Views: 10,070

Hi Dan,

❝ The longest elimination half life (either drug1 or drug2) determines the duration of each period, right?

Not necessarily. We once performed a DDI with two drugs of very different half-lives (3 and 16 hours) and had a shorter phase for drug A only. I would not recommend that. Logistics was nasty and volunteers were confused. Keep it simple and follow your suggestion.

❝ Allocation of subjects to sequences according to William´s design, right?

If you read in between the lines (BE-GL p.22 about ODTs), yes. Some forum members don’t see the necessity of keeping variance balanced if carry-over is not part of in the model. Given that, a 3×3 Latin Square should do as well. Up to you.

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Complete thread:

drug-drug interaction in steady state? Dr_Dan 2014-12-08 17:31
- DDI only in steady state Helmut 2014-12-08 17:43
  - DDI only in steady state Dr_Dan 2014-12-08 18:15
    - DDI only in steady stateHelmut 2014-12-08 18:30
      - DDI only in steady state felipeberlinski 2014-12-18 17:37
        
        DDI only in steady state Helmut 2014-12-18 17:59
      - DDI only in steady state Dr_Dan 2015-01-07 15:42
        
        DDI active wash-out Dr_Dan 2015-01-09 12:04
        
        DDI active wash-out nobody 2015-01-09 15:03
        DDI active wash-out Dr_Dan 2015-01-09 15:59
        
        DDI active wash-out nobody 2015-01-09 16:38