Biomedical Engineering Reference
In-Depth Information
Despite the potential QSP models may have in directly impacting drug develop-
ment and patient care, there are several challenges in the wide-spread development
and use of such approaches. The development of detailed, mechanistic models is
time-consuming and requires significant, and at times very costly, data to generate
and validate. Additionally, the development of such models requires a broad
knowledge-base as principles of biology, physiology, biochemistry, pharmacology,
are incorporated with engineering, computer science or programming, and statis-
tics, requiring inter-disciplinary teams and training programs. QSP is a promising
approach and the utilization of these types of QSP models in conjunction with
molecular and genomic information is a scientifically rational approach for defining
optimal multidrug regimens, identifying responsive patient populations, identifying
translational biomarkers, and designing clinical trials.
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