Bioequivalence and Bioavailability Forum

Dear All,

By using the only power and sample size how we can calculate the N for NTI molecules. what about the other parameters.

Calculating the probability of passing (power) and the sample size (to meet a desired power target) are just two sides of the same coin. One determines the power at a fixed value of n (number of subjects) and the other determines n for a fixed value of power.

FDA published a paper that gives the results of the correct simulations; Jiang W, et al, A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion, The AAPS Journal, 17(4), 2015.

Please provide your valuable suggestion on the same, for my understanding the same.

---

Edit: I deleted another post with identical text. Please follow the Forum’s Policy. I activated the PM-function and edited your profile. [Helmut]