The need to pursue and publish clinical trials in nanomedicine.

When I became Editor in Chief of Wiley’s WIREs Nanomedicine and Nanobiotechnology, I felt one of the most important issues was that the publication is dedicated to nanomedicines. This essentially suggested that nanotechnology would be transitioning into the actual development of human therapeutics. Recently, this movement has begun. We have seen the initiation of multiple clinical trials of nanomaterials both for therapeutics and for medical devices. While this is exciting and encouraging, it is important to realize that nanotechnology now has to come to grips with the regulatory issues associated with a therapeutic approval process. This process is complex and expensive, but is necessary regardless of the nanomaterial or application. Many individuals who specialize in material science, analytical chemistry, or physics have not had prior experience with the regulatory process for either human therapeutics or medical devices. As such, I think it is worthwhile to review briefly the approval process for a human therapeutic. First, while the procedures required to approve a drug were varied around the world, there has been recent convergence to these processes facilitated by the International Conference on Harmonization. Fundamental to the development process is the ability to characterize critical product attributes that ensure the identity, strength, quality, purity, and potency of the final product. New technologies will require new approaches to accomplish this assessment. In addition, at least four different sets of studies are necessary before a product can be submitted for approval for use in humans. Animal toxicity studies must first be done and under processes that are called good laboratory practices (GLP). These studies often require that more than one species be tested, usually a rodent and another non-rodent species, to ensure that anticipated and even unexpected toxicities are identified and characterized so the material can be