Go/No-go Decision for Pivotal Study [Power / Sample Size]

posted by NK – India, 2023-12-27 13:15 (114 d 22:50 ago) – Posting: # 23813
Views: 1,373

Dear All,


How to simulate the pilot BE study data?

For example, if the pilot study data available for 14 subjects (Eg. T/R ratio is 84% & 90% CI is 79 to 89), I would like to know if we perform the pivotal study with the same test formulation in higher sample size (based on the intra CV), what would be the results? (Eg. in 36 subjects or 48 subjects).

This will help us to take decision whether go/no go for the pivotal BE study.


Edit: Category changed; see also this post #1[Helmut]

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