1 reply to this topic

[f_yc]

Dear Support,

 

Can Phoenix implements"In Vitro Population Bioequivalence like Budesonide" ?

 

I noticed that Excel VBA can*, R language can**, but Phoenix can't, can you implement this PBE method in Phoenix?

 

The budesonide guide is:
https://www.fda.gov/...s/UCM319977.pdf

 

 

The following documents are attached:

FDA's Guide to Budesonide

Data from the FDA's Budesonide Guide

 

*https://forum.bebac....id=17460#p17737

**DIO：10.13699/j.cnki.1001-6821.2018.23.025

 

[Simon Davis]

Dear F_YC, I don't think this is a trivial matter; I haven't looked into it personally but I recall conversations on the BEBAC forum like this one;

 

http://forum.bebac.a...ry.php?id=16473

 

If you have the R code or a copy of the VBA please share it, since I haven't seen it and it's not in the links you post above.  The FDA doc has some formula's but no code and the BEBAC threads above comment;

 

"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"

 

https://forum.bebac....=17460#top17481

 

  Simon.

 

 thanks.