Safety Considerations

Other than characterization, the other major consideration has to do with safety. However, it is only within the context of adequately characterized products that safety studies provide value. Therefore, although safety is instinctively the primary concern, adequate characterization of nanomaterials has to precede any studies on safety.

As particle size decreases, there may be size-specific effects. These effects may impact safety if the materials are more reactive. It has been mentioned in numerous discussions that, as particle size decreases, reactivity is expected to rise. The increased reactivity combined with the decreased size has led us to pose many questions. Some of these questions are listed below:

1. Will nanoparticles gain access to tissues and cells that normally would be bypassed by larger particles?

2. If nanoparticles enter cells, what effects do they have on cellular and tissue functions? Are the effects transient or permanent? Might there be different effects in different cell types, depending on specific tissue targets or receptors?

3. Once nanoparticles enter tissues, how long do they remain there and where do they concentrate?

4. What are the mechanisms by which nanoparticles are cleared from tissues and blood and how can their clearance be measured?

5. What are some route-specific issues for nanomaterials, and how are these issues different than for other types of materials that are not in the nanoscale?

6. With regards to ADME, specific questions include:

a. What are the differences in the ADME profile for nanoparticles versus larger particles of the same drug?

b. Are current methods used for measuring drug levels in blood and tissues adequate for assessing levels of nanoparticles (appropriateness of method, limits of detection)?

c. How accurate are mass balance studies, especially if the levels of drug administered are very low; i.e., can 100% of the amount of the administered drug be accounted for?

d. How is clearance of targeted nanoparticles accurately assessed?

e. If nanoparticles concentrate in a particular tissue, how can clearance be accurately determined?

f. Can nanoparticles be successfully labeled for ADME studies?

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