The Product Quality Research Institute (PQRI) will hold a January 14-15, 2014, workshop on “Nanomaterial Drug Products: Current Experience and Management of Potential Risks.” The goals and objectives of the workshop, which is co-sponsored by the United States Pharmacopeia (USP) and American Association of Pharmaceutical Scientists (AAPS) and endorsed by the Society of Toxicology (SOT) are to:
- Review analytical science and methods for characterizing nanomaterials;
- Share experiences and results using multiple formulation platforms for the same active pharmaceutical ingredient (API);
- Discuss approaches to the management of potential risks of nanomaterials in drug products starting from early drug development and throughout the product lifecycle;
- Gather input regarding the considerations for utilizing nanotechnology in pharmaceutical products;
- Present experience and perspectives from international regulatory agencies and standards setting organizations on the use of nanotechnology in pharmaceutical products; and
- Discuss areas where additional research on the effects of nanosize APIs on absorption, distribution, metabolism, elimination, and toxicity may be needed.
The expected outcomes are to establish opportunities for collaboration between academia, industry, and government-sponsored research programs and develop a summary report of the workshop discussions and recommendations.