The work proposed in this application is an integral part of a large research in cancer pharmacology directed at the development of new therapeutic principles using nanotechnology. Nanoscale particles and devices are similar in size to biomolecules and can easily enter most cells. Our ability to manipulate the physical, chemical, and biological properties of these particles affords researchers the ability to engineer and use nanoparticles for drug delivery, as image contrast agents, and for diagnostic purposes. Scientists in this Center will be generating nanoscale particles and devices, made out of novel materials that are intended for use in man. The Center will perform preclinical toxicology, pharmacology, and efficacy testing of nanoscale devices using animal models and cultured human cell lines. Pharmacologic and toxicologic assessment of these particles in animal models is an essential step in their preclinical development. The mission of Pharmacology and Toxicology Resource (PTR) will be to provide GLP pharmacokinetic (PK), pharmacodynamic (PD) and toxicologic (TOX) services to Center investigators utilizing the assay cascade and protocols developed by the Nanotechnology Characterization Laboratory for Cancer Research in conjunction with the FDA. In vivo studies will be carried out in mice and rats; in vitro studies will utilize human cell lines.
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