Bioequivalence and Bioavailability Forum

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 is hopelessly outdated and notorious for typos… The current one is of 2018.

Ok, thank you. So, correction for potency is no longer described in Canadian guidelines?

❝ Why are you interested in reproducing such stuff?

For Validation purposes.

❝ 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. 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. 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.

Thank you for the provided references, but I need data to validate potency correction equations.

---

Edit: Standard quotes restored; see also this post #8. [Helmut]