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

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1

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/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319977.pdf

The following documents are attached:
FDA’s Guide to Budesonide
Data from the FDA’s Budesonide Guide

*https://forum.bebac.at/mix_entry.php?id=17460#p17737
**DIO：10.13699/j.cnki.1001-6821.2018.23.025

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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.at/mix_entry.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.at/mix_entry.php?id=17460#top17481

Simon.

thanks.