Scientific Considerations For The Development Of Nanotechnology Products

Ensuring the safety of nanomaterials in drug applications is one of the most important concerns for regulators and drug developers. However, as important as safety is, it is also important to adequately characterize the nanomaterials used in drug products. Proper characterization and manufacturing procedures will ensure that a consistent product is being used, both during precli-nical and clinical development, and after approval. Some of the questions that have been raised internally regarding the assurance of safety of nanomaterial-containing products, as well as questions regarding characterization, are listed below. It is not within the scope of this chapter to address questions regarding manufacturing and scale-up; however, it should be noted that this is an issue that needs serious consideration, because unique characteristics of nanotechnology products are likely to require unique manufacturing procedures.

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