Typos… [Regulatives / Guidelines]
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 is hopelessly outdated and notorious for typos… The current one is of 2018.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:
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.
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 is hopelessly outdated and notorious for typos… The current one is of 2018.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 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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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… Shatha 2022-03-20 16:03
- Wrong formula for CV Helmut 2022-03-20 16:57
- Typos…Helmut 2022-03-20 15:08