in vitro- in vivo correlations (IVIVC)

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  • Published date: May 23, 2019
    • Shirley, New York, United States

During the total process of drug development, formulation optimization represents a critical aspect to ensure the quality of pharmaceutical products. However, the formulation optimization is always a complex and time consuming procedure that generally requires alteration in composition, excipients, batch sizes and manufacturing parameters. Moreover, the composition or other characteristic changes of the formulation may lead to a change of in vivo pharmacokinetics. Therefore, a corresponding bioequivalence study is required to be done for proving the similarity of the new formulation. The in vitro- in vivo correlations (IVIVC) represents the mathematical relationship between an in vitro property of the formulation (the in vitro release data of a dosage form) and its in vivo act (generally reflected by the time course of the plasma concentration of API). In this case, a comprehensive understanding of the correlations between in vitro and in vivo data are of great importance to the drug development and optimization of formulation, since it can significantly reduce the research time and expenditure.

BOC Sciences has a wealth of expertise in formulation development and analysis of products for quality control. Our experts are well aware of that a good correlation is a very useful tool for predicting in vivo results based on the in vitro data and allows dosage form optimization with the fewest possible trials in mankind. Generally, based on the ability of the correlation to reflect the complete plasma drug level-time profile, there are four levels of IVIVC (levels A, B, C, and multiple C) according to the description of FDA.

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Alex Brown
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