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Abstract:
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An IVIVC model describes the relationship between an in vitro property of a dosage form and a relevant in vivo response. IVIVC models find multiple practical applications within the pharmaceutical research, e.g. in reducing the number of human studies during the clinical development (CDER, 1997). Initial work on IVIVC modeling was done two decades ago (Gillespie et al., 1985) with the introduction of the so-called deconvolution method. This method, however, has some drawbacks and O'Hara et al. (2001) developed an alternative, based on a convolution procedure and involving a two-stage analysis. We developed a convolution-based procedure, novel in involving a one-stage approach and allowing mixture distributions for heterogeneous formulations (Jacobs et al., 2006). The method is successfully applied to a Galantamine controlled release formulation, a treatment for Alzheimer's disease.
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