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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.
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