However, the deuterium role in complex biological systems has not been fully established, which requires further studies in the
IVIVC system.
Various
IVIVC studies have been published for a number of formulations, including Busprion, propranolol, nevirapine, metoprolol and other drugs.
IVIVC is a biopharmaceutical tool used in drug development and formulation optimization to demonstrate that equivalence.
Caption: FIGURE 10: Linear regression multiple-level C
IVIVC correlation models for (a) Madopar HBS capsules; (b) PXLNET matrices; and (c) IPB matrices.
Thus, in principle, the establishment of in vitro-in vivo correlations (
IVIVCs), whereby the dissolution rate may serve as a surrogate for systemic exposure (e.g., bioavailability, "area under the curve" (AUC), or [C.sub.max]), is highly desirable because it could reduce the number of BE studies required for generic drug product development and registration (4).
The RA values were used to determine the
IVIVC between liver damage and the assays.
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. En todas las comparaciones se demostraron valores de regresion lineal por minimos cuadrados con factores de correlacion cercanos o superiores 0.90, en la combinacion de comparaciones como:
Statistical moment analysis is applied to determine level B
IVIVC. In this level of correlation, the mean in-vitro dissolution time (MDT vitro) of the product is compared to either mean in-vivo residence time (MRT) or the mean in-vivo dissolution time (MDT vivo).
Pathak, "Wet process-induced phase-transited drug delivery system: a means for achieving osmotic, controlled, and level A
IVIVC for poorly water-soluble drug," Drug Development and Industrial Pharmacy, vol.
Establishing an
IVIVC (in vitro in vivo correlation) remains a challenge for non-oral dosage forms like long acting injectables.
Gupta, "In vitroin vivo correlation (
IVIVC) study of leflunomide loaded microspheres,' International Journal of Pharmacy and Pharmaceutical Sciences, vol.