FDA building disease models
FDA and the drug development software firm Pharsight have entered into a cooperative research and development agreement to license software modules for "the analysis, visualization, storage, reporting and review of pharmacokinectic/pharmacodynamic data" and development of a "repository for the data needed for modeling and simulation" as well as support for the Clinical Data Interchange Standards Consortium, the company says. FDA says the agreement will help the agency apply model-based drug development tools to regulatory decisions and build disease, placebo, dropout and drug efficacy/safety models...
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