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Back to the forum  2018-06-21 19:49 CEST (UTC+2h)
liviacarol
Junior

Brazil,
2017-06-07 22:24

Posting: # 17460
Views: 2,431
 

 Software for inhaler bioequivalence [Software]

Hello to all.
I would like to test some data for test and reference products regarding in vitro bioequivalence. I would like to perform the statistic analysis referred by FDA for budesonide (suspension). Can someone provide me an excel sheet or an addon for excel and explain me how to use it to perform in vitro bioequivalence test?
Thank you kindly.

The budesonide guide is:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319977.pdf
ElMaestro
Hero

Denmark,
2017-06-10 11:28

@ liviacarol
Posting: # 17481
Views: 1,903
 

 Software for inhaler bioequivalence

Hi Liviacarol,

» I would like to test some data for test and reference products regarding in vitro bioequivalence. I would like to perform the statistic analysis referred by FDA for budesonide (suspension). Can someone provide me an excel sheet or an addon for excel and explain me how to use it to perform in vitro bioequivalence test?

I don't think I have seen any free software on the internet for this but I haven't looked much for it either. Excel can do it, yes, but it does require a bit of a complicated spreadsheet setup or VBA programming.

If you wish, then feel free to send a dataset here in more or less the same format as in the FDA guidance table section B (the example). I will then try to analyze it with R, assuming you have beginning-middle-end data.

Note, though, that FDA's equations require that there are no missing values (not even a single one!) and that ideally the number of units per lot is the same between T and R

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
yicaoting
Regular

NanKing, China,
2017-08-22 18:46

@ ElMaestro
Posting: # 17737
Views: 1,334
 

 Software for inhaler bioequivalence

» I don't think I have seen any free software on the internet for this but I haven't looked much for it either. Excel can do it, yes, but it does require a bit of a complicated spreadsheet setup or VBA programming.

Dear ElMaestro,
I have developed a VBA program in Excel for analysis of the inhalation BE as FDA's guidance for budesonide.
I am willing to analysis sunch data for all of guests here.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
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