Development of a computational platform to investigate reports of adverse events attributed to generic drugs

University Of Florida, Gainesville FL

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Abstract

Project Summary This research is intended to develop 3 computational pathways which will be used to investigate adverse events (AEs) reported for generic drugs, as well as to predict the relative risk of AEs for brand name drugs coming off patent in the next 5 years. The 3 computational pathways are: 1. A physiologically based PK model that integrates drug and formulation properties with biologic system properties to predict exposure to a drug product (PK). Sensitivity analysis is used to identify factors which are most likely to cause differences in PK between a generic and brand name product. 2. An empirical PK/PD model which simulates the clinical response of two drug products with different PK profiles as a function of time after administration. The PD profiles are compared to determine how sensitive they are to changes in PK. 3. A system pharmacology model that maps the targets and pathways of a drug to determine the likelihood of that drug causing the purported AEs. The model includes other drugs which are positive controls for the AE of interest to determine similarity of target and pathway with the generic drug.