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Provides services to facilitate preclinical development of materials that are derived from biotechnology processes. Services will be conducted at the appropriate regulatory compliance level dependent on the stage of product development.
The Interventional Agent Development Services program provides services to facilitate preclinical development of therapeutics and new in vivo diagnostics for infectious disease-causing pathogens and/or toxins.
Note: Devices are excluded.
The Phase I Clinical Trial Units for Therapeutics support the design, development, implementation, and conduct of Phase I clinical trials to assess safety, pharmacokinetics, and/or pharmacodynamics of licensed and investigational therapeutic products, including immunomodulatory agents and monoclo