The primary goal is to provide the computational services available to all the investigators that will allow them to fulfill their specific aims. In each instance, there will be a need to examine the data generated from the in vitro hollow fiber system experiments and animal model experiments, fit models to the data and translate this insight to the clinical arena so that appropriate doses and schedules can be chosen for treatment. This Core describes the process by which the data developed from the hollow fiber system studies (or animal studies, where necessary) are analyzed and translated to clinical doses and schedules. It is impossible to perform classical clinical trials to determine doses and schedules of drugs for emerging infectious disease such as SARS or for intentional release of bioterror agents. We have developed a new paradigm for robustly determining doses and schedules of drugs for agents for these situations. Because of the seriousness of these illnesses, drug doses and schedules have to be right the first time. In addition to being able to set drug exposure targets employing a validated in vitro hollow fiber infection model, we have developed a robust approach employing Monte Carlo simulation for translating the insights from the in vitro system (or animal model, where available) to man. This will provide the computational expertise and the infrastructure support to help solve this serious national problem.
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