In Vivo Pharmacokinetic And Toxicological Assessments

As is the case with any NCE, a thorough understanding of the properties that govern biocompat-ability is necessary to allow transition of nanomaterials to human clinical trials. Although in vitro toxicology studies can be informative, the obvious caveat is that phenomenon observed in vitro may not materialize in vivo due to differences in biological response or nanoparticle concentrations. Therefore, nanoparticle safety and therapeutic efficacy can only be definitively assessed by rigorous in vivo testing. This phase is guided in part by insights obtained from the physicochemical and in vitro characterization programs.

The primary goal of in vivo studies is to evaluate nanomaterials' pharmacokinetics, safety, and efficacy (see Table 7.1) in the most appropriate animal models. Preclinical toxicological and pharmacokinetic studies are conducted in accordance with the FDA regulatory guidance for IND and IDE submission. It is not within the scope of this chapter to review this regulatory guidance; instead, the reader is directed to the regulatory chapter of this text. While it is generally agreed that the current in vivo pharmacological and toxicological endpoints used for devices and small molecule drugs should be appropriate in assessing the safety and efficacy of biomedical nanoma-terials, the qualities of nanomaterials that lend themselves to biomedical application, such as

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