The main goal of the Drug Translation and Development Core Is to facilitate each scientific project in the development of potential radiation mitigators for various organ systems, including lung (Project 1), CNS (Project 2), skin (Project 3), and bone marrow (Project 4) in the context of a total body radiation exposure. This Core will monitor the progress of testing these agents with respect to the efficacy, safety, toxicology, pharmacokinetics, pharmacodynamics, and quality assurance. As a result, Core D hopes to be able to make recommendations regarding regulatory requirement and, ultimately, will be in a position to recommend strategies towards the development of clinical studies and ultimate drug approval by FDA.
Each Project has candidate agents for radiation mitigation, with several agents being tested across Projects. The drug development process will be focused on pre-clinical development. The formulation of the agents and pre-clinical development in animal models will be centrally recorded and efficacy validated by central statistical analyses (see Biostatistics). The stepwise approach of pre-clinical pharmacology will include demonstration of efficacy in vivo in organs of interest (see all project Research Plans), as well as pharmacokinetics and pharmacodynamic investigations in animal injury models, including combined injury. Candidate agents with promising efficacy and low toxicity in animal models may be considered for clinical development through independent funding.
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