Bioequivalence and Bioavailability Forum • CVintra for Cmax > AUC, therefore use AUC for sample size?

CVintra for Cmax > AUC, therefore use AUC for sample size? [Power / Sample Size]

posted by Helmut - Vienna, Austria, 2017-08-07 18:40 - Posting: # 17674
Views: 988

Hi nobody,

» Found this here:
» https://www.ncbi.nlm.nih.gov/pubmed/28257283
» […] if I understand this correctly, the authors say, CVintra for Cmax is generally higher than for AUC, therefore use AUC to estimate the sample size of your study.

Ah – the formerly pink, now black journal. ;-)

» Did I get this right?

At least this is what the last sentence of the abstract says: “Hence, CV derived from AUC instead of C_max should be used in sample-size calculation to achieve a sufficient, yet practical, test power. ”

» Any thoughts on this approach?

Outright bizarre. Since the authors are of a CRO, maybe the love failed studies in order to repeat them? Do you have a copy to share?

—

All the best,
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

CVintra for Cmax > AUC, therefore use AUC for sample size? - nobody, 2017-08-07 17:14 [Power / Sample Size]
- CVintra for Cmax > AUC, therefore use AUC for sample size? - Helmut, 2017-08-07 18:40
  - CVintra for Cmax > AUC, therefore use AUC for sample size? - nobody, 2017-08-07 19:52
    - Crap… - Helmut, 2017-08-07 20:29
      - Crap… - nobody, 2017-08-07 21:31
- CVintra for Cmax > AUC, therefore use AUC for sample size? - ElMaestro, 2017-08-07 23:04
  - CVintra for Cmax > AUC, therefore use AUC for sample size? - nobody, 2017-08-08 10:06
- CVintra for Cmax > AUC, therefore use AUC for sample size? - jag009, 2017-08-09 06:21
  - CVintra for Cmax > AUC, therefore use AUC for sample size? - nobody, 2017-08-09 17:11