Table 1.

Bridging the bench-bed gap. Summary of the key pre-clinical characterizations included in the standardized analytical cascade set by the Nanotechnology Characterization Lab (NCL) to guide both academic and non-academic research labs to gather required data for filing an investigational new drug application to the FDA

1. Physico-chemical characterization	2. In Vitro Characterization	3. In Vivo Characterization	4. Design of clinical trial and patient pre-selection
Physical properties: size, density, surface area, porosity, etc.	LAL Assays	Efficacy evaluation: therapeutics, imaging	Evaluation of the extent of EPR: MRI, PET imaging, etc. before and during clinical trials.
Surface characterization: charge, hydrophilicity, surface chemistry, solubility, etc.	Targeting efficiency: cell binding and internalization	Disposition: Tissue distribution, clearance, half-life, exposure, etc.	Target receptor profiling: MRI, PET imaging, immune staining of tumor biopsies, etc.
Stability assessment	Drug release	Single-and repeated-dose toxicity
Batch-to-batch reproducibility: purity, sterility, uniformity, etc.	Immunological evaluation: hemolysis, platelet aggregation, plasma corona, complement activation, phagocytosis, cytokine release, etc.	Immunotoxicity
	Toxicity: oxidative stress, cytotoxicity, etc.
	Efficacy evaluation