dshah
★★  

India,
2025-02-10 08:27
(40 d 14:59 ago)

Posting: # 24356
Views: 582
 

 Method A of EMA [Software]

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Hi All!
I was trying to calculate 90% CI using excel and found difference with the reported values.
I am using below formula for getting margin of error.
Margin of error=CONFIDENCE.T(ALPHA, STD_DEV,SIZE)

Where ALPHA=1-%CI=0.1
Is this the correct approach?
Thank you,
Divyen

Edit: Category changed. [Helmut]
 
Helmut
★★★
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Vienna, Austria,
2025-02-10 11:28
(40 d 11:57 ago)

@ dshah
Posting: # 24357
Views: 476
 

 ABEL: Why Excel?

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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 [image]-package replicateBE.3

  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
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dshah
★★  

India,
2025-02-10 16:40
(40 d 06:46 ago)

@ Helmut
Posting: # 24358
Views: 457
 

 ABEL: Why Excel?

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Thank you Helmut!

❝ Sorry, no idea about Excel but out of sheer curiosity: Why do you want to use it?


There is licensing issue going on, so was exploring Exel.

❝ 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 [image]-package replicateBE.


I will try R and may trouble forum member with other questions :lookaround:

Thanks,
Divyen
 
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