Bioequivalence and Bioavailability Forum • sample size for TSD is better than for 1SD?

sample size for TSD is better than for 1SD? [Power / Sample Size]

posted by mittyri – Russia, 2024-01-01 20:54 (288 d 08:35 ago) – Posting: # 23817
Views: 1,758

Hi Helmut,

naive question

❝ Maurer(n1 = 24, CV1 = 0.0886, GMR1 = 0.84)

❝ <...>

❝ - Calculated n2 = 12

❝ - Decision: Continue to stage 2 with 12 subjects

does it mean that TSD is more attractive due to lower sample size? That's significantly lower than 'Carved in stone'! I did not expect that with corrected PIE

—
Kind regards,
Mittyri

Complete thread:

Go/No-go Decision for Pivotal Study NK 2023-12-27 12:15 [Power / Sample Size]
- Problematic T/R-ratio… Helmut 2023-12-27 13:27
  - TSD? Helmut 2024-01-01 13:50
    - sample size for TSD is better than for 1SD?mittyri 2024-01-01 19:54