Bioequivalence and Bioavailability Forum

Tóthfalusi et al. (2009) [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2012-10-12 19:37 (4993 d 19:32 ago) – Posting: # 9408
Views: 9,654

Hi John!

❝ Could you provide the reference for the Laszlos paper?

Tóthfalusi L, Endrényi L, García Arieta A. Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence. Clin Pharmacokinet. 2009;48(11):725–43. doi:10.2165/11318040-000000000-00000

These simulations (GMR restriction 0.8–1.25, CV 35, 45, 55%; each data point representing 10 000 studies) are based on a TRT|RTR design in 36 subjects. Circles: unscaled, squares: EMA’s method (without the 50% cap – paper published before the BE-GL), triangles: FDA’s method. Studies passing = empiric power.

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


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Complete thread:

• Precision of CVwr in replicate designs Helmut 2012-10-11 17:29 
  • Precision of CVwr in replicate designs jag009 2012-10-12 16:52
    • Tóthfalusi et al. (2009)Helmut 2012-10-12 17:37
  • Precision of CVwr in replicate designs d_labes 2012-10-17 10:40
    • Great post! Helmut 2012-10-17 15:28
      • Nice to know? d_labes 2012-10-17 16:39
        • Nice to know! Helmut 2012-10-17 19:11