Old references… [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2021-09-13 15:52 (335 d 17:47 ago) – Posting: # 22569
Views: 860

Hi Selwa,

» Hello dear community, I need to download a PDF article which I did not have access to, and at the same time I would like to have references if possible in the same subject: calculation of the number of subjects in bioequivalence and evaluation of sample size.

A more exhaustive list (also quoted in the article you mentioned) is given by Steinijans et al.*

» Référence of the article : Estimated coefficient of variation values for sample size planning bioequivalence studies DOI:10.5414/CPP39037.

I have it. If you want I can send you a scan. However, old references are problematic. You have no clue about the clinical performance and the bioanalytical methods used. Therefore, you should be extremely cautious relying on the reported values.
If you want to design a study, I suggest to find recent publications about the drug you are interested in. The FDA’s ANDA files and European Public Assessment Reports are helpful. An advice: The larger a study is, the more reliable the reported variability. If the CV is not given, you can calculate it from the confidence interval, the design, and the sample size (see there).

  1. Steinijans VW, Sauter R, Hauschke D, Diletti E, Schall R, Luus HG, Elze E, Blume H, Hoffmann C, Franke G, Siegmund W. Reference tables for the intrasubject coefficient of variation in bioequivalence studies. Int J Clin Pharm Therap. 1995; 33(8): 427-430. PMID 8556220.

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