Bioequivalence and Bioavailability Forum • More information, please

More information, please [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2026-05-13 10:53 (21 d 22:12 ago) – Posting: # 24620
Views: 1,097

Hi Marty,

before diving into the details of your post, can you give further information?

theta0 you used in planning the pivotal study, target power (CV 0.18, right?)
Number of eligible subjects in the failed study (CV 0.27, PE 0.88)

Before talking to the guy in the Armani suit see the Bayesian stuff for sample size estimation based on a previous study and statistical assurance.*

Ring A, Lang B, Kazaroho C, Labes D, Schall R, Schütz H. Sample size determination in bioequivalence studies using statistical assurance. Br J Clin Pharmacol. 2019; 85(10): 2369–77. doi:10.1111/bcp.14055. Open access.

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Complete thread:

Sample size with theta0 < 0.95: any regulatory pushback? Martynkf 2026-05-12 13:23
- Sample size with theta0 < 0.95: Why not? Helmut 2026-05-12 14:55
  - Repeating Studies zizou 2026-05-22 16:11
    - Buongiorno, signor Bonferroni! Helmut 2026-05-23 08:30
      - Buongiorno, signor Bonferroni! ElMaestro 2026-05-25 17:13
- Sample size with theta0 < 0.95: any regulatory pushback? ElMaestro 2026-05-13 01:26
  - Sample size with theta0 < 0.95: any regulatory pushback? Martynkf 2026-05-13 08:27
    - More information, pleaseHelmut 2026-05-13 08:53
      - More information, please Martynkf 2026-05-13 10:27
        
        Still 🤔 Helmut 2026-05-13 13:25
        
        Still 🤔 Martynkf 2026-05-15 08:02

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