Sample size based on worst case [Power / Sample Size]

posted by Helmut Homepage – 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.

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Helmut Schütz

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