Sample size based on worst case [Power / Sample Size]
❝ […] 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.
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- Multiple dose design Sample size Researcher101 2020-10-14 10:21 [Power / Sample Size]