Bioequivalence and Bioavailability Forum • Typos…

Typos… [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2022-03-20 16:08 (761 d 06:14 ago) – Posting: # 22845
Views: 1,486

Hi Shatha,

this guidance (of 1996!) is hopelessly outdated and notorious for typos… The current one is of 2018.

Why are you interested in reproducing such stuff? If for validation purposes, consider this series of articles instead:

Schütz H, Labes D, Fuglsang A. Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies. AAPS J. 2014; 16(6): 1292–7. doi:10.1208/s12248-014-9661-0. Free Full text.
Fuglsang A, Schütz H, Labes D. Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design. AAPS J. 2015; 17(2): 400–4. doi:10.1208/s12248-014-9704-6. Free Full text.
Schütz H, Tomashevskiy M, Labes D, Shitova A, González-de la Parra M, Fuglsang A. Reference Datasets for Studies in a Replicate Design intended for Average Bioequivalence with Expanding Limits. AAPS J. 2020; 22(2): Article 44. doi:10.1208/s12248-020-0427-6.

Edit: Just checked C_max of TABLE 11-T. You are correct.$$\small{\{L,U\}=100\exp(-0.2708+0.0360\,\mp 1.812\times0.0799)\approx \{68.41\%,91.39\%\}}$$Not rocket science.

—
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Helmut Schütz

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Complete thread:

Corrections for Potency Shatha 2022-03-20 14:51 [Regulatives / Guidelines]
- Typos…Helmut 2022-03-20 15:08
  - Typos… Shatha 2022-03-20 15:57
    - Typos… Helmut 2022-03-20 16:32
      - Typos… Shatha 2022-03-21 10:02
  - Typos… Shatha 2022-03-20 16:03
    - Wrong formula for CV Helmut 2022-03-20 16:57