Bioequivalence and Bioavailability Forum

4x4-fasting-fed study [Design Issues]

posted by Helmut  – Vienna, Austria, 2014-04-04 16:00 (4470 d 00:06 ago) – Posting: # 12772
Views: 7,709

Dear beman,

since I suggested #2 in a comment to the BE-GL, you may guess which one is my favorite.

• Con: Since period effects are not accounted for in the design, standardization is crucial.
  
• Pro:  If you are not sure about the CV, you could go with a Two-Stage Design and – if a second stage is necessary and CVs in fasting/fed states are different – use different sample sizes.

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For an example of beman’s #2 see:

• Vaz-da-Silva M, Loureiro AI, Nunes T, Maia J, Tavares S, Falcão A, Silveira P, Almeida L, and P Soares-da-Silva
  Bioavailability and Bioequivalence of Two Enteric-Coated Formulations of Omeprazole in Fasting and Fed Conditions
  Clin Drug Invest 25(6), 391–9 (2005)
  online

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• 4x4-fasting-fed study beman 2014-04-04 13:48 [Design Issues] 
  • 4x4-fasting-fed studyHelmut 2014-04-04 14:00
    • Two stage design in a 4 way crossover fasting-fed BE study Tina 2014-05-16 10:35
      • TSD: 2 cross-overs Helmut 2014-05-16 12:03
  • 4x4-fasting-fed study Dr_Dan 2014-04-04 19:44
    • 4x4-fasting-fed study Tina 2014-05-16 12:31