ABSTRACT
Unequivocally, nanotechnology is quickly becoming a vanguard with respect to drug delivery systems. This results from the fact that products of this technology such as nanoparticles can be used to treat a wide variety of challenging diseases including diabetes, thromboses, heart disease, neurodegenerative disorders, and cancer, for which therapeutic alternatives are limited. However, as with any new
PART IV: CLINICAL, ETHICAL, AND REGULATORY ISSUES
technology, the risks of nanoparticulate systemsmust be heavily researched to ensure that the advantages of therapeutic treatment far outweigh any possible side effects. The pharmaceutical manufacturers are primarily responsible for ensuring the safety and efficacy of nanoparticles for clinical use. The United States Food and Drug Administration (FDA) is the authority that ensures that the nanoparticle-based products meet the regulatory standards for approval. The purpose of this chapter is to briefly summarize the clinical progress to date with nanoparticles, the most tangible therapeutic systems of nanotechnology, and the ethical issues and regulatory challenges associated with the products of nanotechnology (1).
CLINICAL ASPECTS
