Bioequivalence and Bioavailability Forum

Hi Divyen,

❝ I was trying to calculate 90% CI using excel...

Sorry, no idea about Excel but out of sheer curiosity: Why do you want to use it? It is not acceptable¹ for the EMA:

Alternative computer programs
SAS […] was used […]. Results obtained by alternative, validated statistical programs are also acceptable except spreadsheets because outputs of spreadsheets are not suitable for secondary assessment.

This article² contains 30 reference datasets as well as the setup of seven softwares (SAS, R, Phoe­nix, STA­TIS­TI­CA, Sta­ta, SPSS, JMP) in its electronic supplementary material. An alternative to commercial software is the -package replicateBE.³

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1. European Medicines Agency. Clinical pharmacology and pharmacokinetics: questions and answers. 3.1 Which statistical method for the analysis of a bioequivalence study does the Agency recommend? EMA/582648/2016. Annex I. London. 21 September 2016. Online.
   
2. 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): 44. doi:10.1208/s12248-020-0427-6
   
3. Schütz H, Tomashevskiy M, Labes D. replicateBE: Average Bioequivalence with Expanding Limits (ABEL). 2022-05-02; Package version 1.1.3. doi:10.32614/CRAN.package.replicateBE