Bioequivalence and Bioavailability Forum • PowerTOST: sampleN.NTIDFDA()

PowerTOST: sampleN.NTIDFDA() [Power / Sample Size]

posted by Mahmoud – Jordan, 2024-02-06 12:45 (514 d 17:08 ago) – Posting: # 23858
Views: 3,521

Dear Helmut

❝ Study design: 2x2x4

❝ log-transformed data (multiplicative model)

❝ 1e+05 studies for each step simulated.

❝

❝ alpha = 0.05, target power = 0.8

❝ CVw(T) = 0.1, CVw(R) = 0.1

❝ True ratio = 0.975

❝ ABE limits = 0.8 ... 1.25

❝ Implied scABEL = 0.9002 ... 1.1108

❝ Regulatory settings: FDA

❝ - Regulatory const. = 1.053605

❝ - 'CVcap' = 0.2142

what do mean about 'CVcap' = 0.2142
Thank you
Mahmoud

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

Sample size calculation for NTI molecules narra1813 2019-08-10 09:21
- PowerTOST: sampleN.NTIDFDA() Helmut 2019-08-10 11:23
  - PowerTOST: sampleN.NTIDFDA()Mahmoud 2024-02-06 11:45
    - 'CVcap' Helmut 2024-02-06 13:51
      - sampleN.NTIDFDA(), power.NTIDFDA, pa.NTIDFDA are deprecated d_labes 2024-02-26 10:54