๐ Statistical Power & Sample Size
Determine the minimum number of vessels required to achieve a reliable f2 result before running a dissolution study. Uses a Monte Carlo bootstrap simulation (up to 10,000 reps per n) to estimate empirical power โ the probability that f2 โฅ 50 is correctly detected when the true profiles are similar.
1 โ Profile Parameters
5 %
Average point-wise difference between test and reference. 0 = identical.
5
Sampling points (e.g. 15, 30, 45, 60 min = 4 points).
8 %
Vessel-to-vessel variability at each time point.
0.6
How correlated adjacent time points are for the same vessel.
Type-I error rate. FDA/EMA practice uses 0.05 or 0.10.
More replications = more accurate but slower. 5,000 is sufficient for most purposes.
2 โ Reference Profile Shape
Reference mean % dissolved at each time point, comma-separated.