Canada: Sample size for Cmax? [Power / Sample Size]
Dear all,
any idea how to estimate sample size for Cmax (PE within 80–125%; no 90% CI)? Nothing is mentioned in the final guidance; the draft stated in Appendix 1 (lines 752–753):
Reminds me on this goodie. No wonder that HPB didn’t introduce scaling for Cmax.
any idea how to estimate sample size for Cmax (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, CVintra 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 Cmax.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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: IUT violated? Helmut 2012-12-29 15:59
- 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
- Canada: IUT violated? d_labes 2012-12-19 14:00