IVIVC is a biopharmaceutical tool used in drug development and formulation optimization to demonstrate that equivalence.
IVIVC technology allows formulation and manufacturing professionals to understand how dissolution parameters affect in vivo drug performance.
Each BA/BE study replaced by IVIVC analysis can shorten the development cycle by months and save hundreds of thousands of dollars.
can be very advantageous to quality control efforts, they are difficult to demonstrate, partly because in vitro dissolution tests do not mimic either the rate or mechanism(s) of drug release in vivo.
The RA values were used to determine the IVIVC between liver damage and the assays.
This result led to an increase of false positives in the later IVIVC analysis, providing a hint that extra experimental ARE data are still needed for analyzing the drug-like compounds of interest in future studies.
En este estudio se logro el proposito de implementar metodologias analiticas, que habitualmente se aplican en la investigacion y desarrollo de nuevos farmacos, para medir propiedades fisicas y biologicas, con resultados coherentes con los obtenidos en los estudios de Biodisponibilidad en sujetos humanos, acordes con los principios de una IVIVC
Multiple level C correlation can be as useful as level A IVIVC from a regulatory point of view.
IVIVC modeling involves three stages, which are 1) model development, 2) model validation, and 3) model application to different scenarios.
For example, Phoenix uniquely offers the ability to perform population PK/PD modeling within a validated environment; the ability to build graphical workflows that can access third party tools such as R, PsN, Xpose, SAS, S-Plus and NONMEM; and the ability to build IVIVC
correlations to optimize bioequivalence trial design, to name but a few.
Module was a key element in the sale of a five year GastroPlus license, which was purchased by a smaller drug delivery company last year.
In our consulting work with clients, we became aware that there was no one software package available that enabled us to perform comprehensive IVIVC
assessments", comments Dr.