The useful indicator of in vivo drug absorption is
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– in vivo correlation (IVIVC) allows prediction of the in vivo performance of a drug based on the in vitro drug release profiles. To develop an effective IVIVC, the physicochemical and biopharmaceutical properties of the drug as well as the physiological environment in the body must be taken into consideration. Key factors include drug solubility, pKa, drug permeability, octanol-water partition coefficient and pH of environment. In general, construction of an IVIVC involves three stages of mathematical manipulation: construct a functional relationship between input (in vitro dissolution) and output (in vivo dissolution); establish a structural relationship using data collected; parameterize the unknowns in the structural model. Some key mathematical relationships used in IVIVC development are presented. The establishment of an effective IVIVC has important implications in quality control and regulatory compliance.
1. Introduction
An in vitro – in vivo correlation (IVIVC) is defined by the U.S Food and Drug Administration (FDA) as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response. Generally the in vitro property is the rate or extent of drug dissolution or release, while the in vivo response is the plasma drug concentration or amount absorbed (FDA, 1997). An important objective of pharmaceutical product development is to gain better understanding of the in vitro and in vivo drug performances. Through the successful development and application of an IVIVC, in vivo drug performance can be predicted from its in vitro behavior. The