Clinical protocols for nanopharmacokinetics assessment

Nanotechnology has created a revolutionary change for the past two decades, with significantly improved precision-based nanomedicine with improved targeted cellular bioavailability, potency, and reduced toxicity in the field of unmet clinical needs. The amalgamation of therapeutics and diagnostics into a single agent of nanoscale range termed as nanotheranostics technique has improved the area of diagnosis and individualized therapy. With this advancement, there is an urgent need for regulatory bodies to understand the science involved and thereby regulate these products to protect public health. The currently available testing approaches are limited and not enough to evaluate nanotoxicology for the clinical translation of the developed nanoscale medicinal products. Several specific techniques are under development for nanomedicines. Currently, there are no specific regulations regarding nanocarriers for drug delivery. There is a need for a dedicated protocol for the evaluation of nanoformulations with concern to the activity, safety, and toxicity of the active molecules as well as the nanocarrier.