How to use Bear for sample size calcu­lation for Xover study [🇷 for BE/BA]

posted by xtianbadillo – Mexico, 2014-12-12 08:27 (3842 d 03:49 ago) – Posting: # 14060
Views: 6,413

How to use Bear for sample size calculation for Crossover study 2x2, power=80, CVintra=.16, BE margins=80-125

description_size
function (parallel = FALSE)
{
  cat("\n")
  cat("****************************************************************************\n")
  cat("                            Required data                                   \n")
  cat("----------------------------------------------------------------------------\n")
  cat(" 1. Theta (%): the target ratio in average BA between the two formulations\n")
  cat("    expressed in percentage of the average reference BA.                    \n")
  cat(" 2. Power (%): the least statistical power to detect (1-Power)          \n")
  cat("    differences between the Test and the Reference formulation.             \n")
  if (parallel) {
    cat(" 3. CV (%): the inter-subject coefficient of variation for parallel  \n")
    cat("    study.                                                                  \n")
  }
  else {
    cat(" 3. CV (%): the intra-subject coefficient of variation for crossover  \n")
    cat("    (or replicate crossover) study.                                         \n")
  }
  cat(" 4. Lower acceptance limit represents the lower BE criteria to be accepted; \n")
  cat("    the upper acceptance limit is equal to 1/(lower acceptance limit).     \n")
  cat("    Usually the lower limit can be 80.000% or, 70.000% in some cases.      \n")
  cat("****************************************************************************\n")
  cat("\n")
  readline(" Press Enter to proceed...")
}
<environment: namespace:bear>

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