In Vivo Characterization

In vivo studies must be conducted to better understand the safety and behavior of nanoparticles in a living organism. As with any new chemical entity (NCE), the nanoparticle formulations' pharmacological and toxicological properties (i.e., ADME/Tox) need to be thoroughly characterized. In vivo studies should include examination of nanoparticles' effects on various organs and systems, such as the liver, heart, kidney, and immune system.

In this chapter, we outline the scientific rationale underlying the development of an assay cascade, with special attention paid to the selection and adaptations of assays and analytical protocols needed to extract meaningful efficacy and safety data from nanomaterials. These are presented in the following four sections: (1) physicochemical characterization, (2) in vitro pharmacology and toxicology assessment, (3) in vivo pharmacology and toxicology assessment, and (4) immunotoxicity. Standardized characterization of nanomaterials will facilitate better inter-laboratory comparison of results and will enhance the quality of scientific data submitted by investigators in support of their IND applications.

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