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RegisterSample size based on worst case [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2020-10-19 16:17 (46 d 15:51 ago) – Posting: # 22030
Views: 348
Hi Researcher101,
» […] sample size in multiple dose studies? Should I estimate sample size based on intra subject variability of Cmin or Cmax or C tau?
Based on the one with highest variability – if the assumed T/R-ratios are identical. If not, explore various combinations and opt for the worst case. This gives you a safety margin for the other PK metrics.
» Can I pool the CVs to estimate sample size?
Doesn’t make any sense.
» […] sample size in multiple dose studies? Should I estimate sample size based on intra subject variability of Cmin or Cmax or C tau?
Based on the one with highest variability – if the assumed T/R-ratios are identical. If not, explore various combinations and opt for the worst case. This gives you a safety margin for the other PK metrics.
» Can I pool the CVs to estimate sample size?
Doesn’t make any sense.
—
Dif-tor heh smusma 🖖
Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Multiple dose design Sample size Researcher101 2020-10-14 10:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- CV of Css,max ≤ CV of Cmax Helmut 2020-10-14 11:27
- Multiple dose design Sample size Researcher101 2020-10-14 13:37
- Sample size based on worst caseHelmut 2020-10-19 16:17
- Multiple dose design Sample size dshah 2020-10-20 06:43
Ing. Helmut Schütz