Author(s) :

Dr. A. S. Narute, Ms. Yogita R. Shirsath.

Volume/Issue :

Abstract :

The In Vitro In Vivo Correlation (IVIVC) method is a useful tool for forecasting bioequivalence between multiple pharmaceutical dosage forms. The concept behind IVIVC is that the in vitro release profile of a drug from dosage form correlates with its in-vivo performance. It is the process of determining whether two or more formulations of the same drug have similar therapeutic effects. The in vitro-in vivo correlation (IVIVC) is a predictive calculation of relationship between the in vitro release of a drug from a dosage form and its in vivo performance. IVIVC can be applied as a tool to help with the development of dissolution specifications for bioequivalence studies. The US FDA defines bioequivalent as the extent to which two products produce the same pharmacologic effect when administered to humans. The IVIVC can be applied to help determine appropriate dissolution specifications for new drug products. In vitroin vivo correlation (IVIVC) is an important tool in the development and regulation of drug products. The goal of IVIVC is to provide a link between the laboratory results and the performance of a drug product in humans. This can help forecast how changes in formulation or manufacturing processes may affect the product's performance.

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