Typos… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-03-20 15:08 (191 d 05:52 ago) – Posting: # 22845
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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 is hopelessly outdated and notorious for typos… The current one is of 2018.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:
  1. 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. [image] Free Full text.
  2. 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. [image] Free Full text.
  3. 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 Cmax 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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