Table 3.

Additional proposed parameters to be considered for nanomedicine characterization

Critical parameter	Description of additional parameters for consideration
Morphology	Bilayer characteristics, if a bilayer is present
	Stability studies over time at different storage temperature
	Stability studies in different media and at specific temperature to simulate biological environment
Stability	Stability studies taking into account in vivo administration (resistance to nebulization, or lyophilization resistance)
	Interaction and stability studies over time with biological environment (e.g., mucin interaction)
	Stability studies in terms of decomposition/degradation of drug loaded inside the nanocarrier in comparison with the free drug
Surface	Surface derivatization (PEG-targeting moieties)
	Polarity, microviscosity, rigidity and distribution of drug substance within nanocarriers, studies of nanocarriers in correlation with release capability
Drug release	In vitro drug release experiments in physiologically, clinically relevant media
	Selection of appropriate in vitro and in vivo models to assess nanomedicine efficacy
Toxicity	Toxicity evaluation of each nanocarrier’s component in comparison with components organized in the nanocarrier structure at the same concentration