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Activity Number: 363
Type: Contributed
Date/Time: Tuesday, August 2, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #321171 View Presentation
Title: An Exposition to Integrated System Modeling of Patients' Safety Risk
Author(s): D. Purkayastha* and Sadhvi Khanna
Companies: and Novartis
Keywords: safety risk ; system modeling ; discrete choice ; Contour structural system matrix
Abstract:

Effective detection of likelihood or pattern in safety risk is an important contemporary issue for safety analyses of clinical data. Identification of a disorder or a pattern of its incidence constitutes a increased risk of a specific adverse events. Routine analyses are performed in a segmented way within a stand-alone body system rather than in an integrated set-up. Here different biomarkers, pharmacokinetics, drug exposure, toxicity and other pathophysiological conditions play an important role on patients' safety status. Generally such interdependent pattern of safety risk with a system approach are ignored in traditional identification process of predictors of safety risk. To have effective detection of safety risk for a disease, this work provides an integrated discrete choice system model of safety risk for multiple body systems. A pattern of safety risk is developed using a contour structural system matrix. Estimated conditional probabilities distribution functions obtained from each individual system is used in the integrated model. This work will provide an alternative statistical methodological approach with an effective identification process for safety risk.


Authors who are presenting talks have a * after their name.

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