Introduction: The biggest challenge faced by the scientific community involved in drug development is to deliver safe and effective dosage of drugs without causing systemic toxicity. Therefore, novel nano-based delivery vehicles specifically targeting tumors but not normal tissues are urgently needed. Areas covered: Nanoparticles have beneficial aspects but can be toxic themselves, which is always a concern for any drug or delivery agent. This review examines and details the toxicological aspects that should be considered when planning to use nanoparticles in animals or in man for drug delivery or imaging. Subjects discussed in this review include i) overviews of applications of various nanoparticles for drug delivery and imaging; ii) toxicological aspects to consider when selecting particular nanoparticles for use in various applications in animals or man; iii) hurdles faced when examining nanoparticle toxicity; and iv) current approaches for assessing nanoparticle toxicity. Expert opinion: Nanotechnology has significant potential for advancing therapeutic efficacy and imaging in cancer; however, these agents can be toxic. Therefore, toxicity needs to be considered when selecting nanoparticles for a particular application. Methods for assessing nanoparticle toxicity need to be improved and standardized across all nanotechnology platforms in order to speed up the application of nanoparticle use in humans.
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