IVIVC with Bioequivalence Data [Dissolution / BCS / IVIVC]

posted by thalita_m  – Brazil, 2019-06-18 01:55  – Posting: # 20329
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Dear all,

I'm a Master Student in Brazil and I'm trying to apply IVIVC with anti-HIV efavirenz.

The thing is:
I have the bioequivalence data from Stocrin and from licensed generic in Brazil and I intend to use this data to establish IVIVC with the dissolution studies in biorelevant means (FaSSIF, FeSSIF, etc).
It is not the classical "FDA-IVIVC" because it is an immediate release drug, and I just have one formulation, with different dissolutions conditions.

I'm trying to establish this without pay-software like GastroPlus or Phoenix. I just tried to calculate Fabs based on Wagner Nelson equation, but the values ​​of Fabs were higher than 1. The Kel is too little. On my work group we have a study that used same in vivo data with GastroPlus and establish the correlation based on one-compartment model, because we do not have intravenous data.

I tried the ivivc for R but Mr. Yung-jin Lee told me that may be not works.

I read the articles of Mr. Langenbucher but my Excel experience is not enough to understand all method. I read here that someone's successfully run the worksheets. Could anyone send me that? And explain me how it woks?

There is another thing, the time scale problem. My in vivo date has 192h and my in vitro date has just 2h30. I read other articles that used Levy's plot to scale time, could any one give me an MS Excel example for this?

I'm learning a lot with the information here, thank you all.

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