Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-06-25 05:38 CEST (UTC+2h)
 
liviacarol
Junior

Brazil,
2017-06-07 22:24

Posting: # 17460
Views: 415
 

 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: 288
 

 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

I could be wrong, but…


Best regards,
ElMaestro

- since June 2017 having an affair with the bootstrap.
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,003 Posts in 3,644 Threads, 1,041 registered users;
32 users online (0 registered, 32 guests).

Everybody is a Bayesian.
It’s just that some know it, and some don’t.    Trivellore Raghunathan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed