Bioequivalence and Bioavailability Forum

Canada: Sample size for Cmax? [Power / Sample Size]

posted by Helmut  – Vienna, Austria, 2012-12-18 19:04 (4928 d 00:00 ago) – Posting: # 9730
Views: 13,796

Dear all,

any idea how to estimate sample size for C_max (PE within 80–125%; no 90% CI)? Nothing is mentioned in the final guidance; the draft stated in Appendix 1 (lines 752–753):

Sample size calculations, based on a standard where only the mean estimate is required to fall within the bioequivalence interval, are not possible.

Don’t agree. It’s easy enough through simulations (i.e., θ₀ 0.95, CV_intra 40%, n 12, power 82.2%). What puzzles me is the lacking consideration of the patient’s risk. With a θ₀ at the limits of the acceptance range by definition 50% of studies will pass – independent from CV and sample size.



Reminds me on this goodie. No wonder that HPB didn’t introduce scaling for C_max.

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


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Complete thread:

• Canada: Sample size for Cmax?Helmut 2012-12-18 18:04 
  • Canada: IUT violated? d_labes 2012-12-19 14:00
    • Canada: IUT violated? Helmut 2012-12-29 15:59
      • IUT d_labes 2012-12-31 13:36
  • Canada: Sample size for Cmax: R-code? VStus 2017-01-19 10:10
    • Canada: Sample size for Cmax: R-code? zizou 2017-01-19 12:20
    • HC: Sample size for AUC and Cmax: exact and sim’s Helmut 2017-01-19 12:30
      • HC: Sample size for AUC and Cmax: exact and sim’s VStus 2017-01-31 13:44