Nanomaterial Drug Products: Current Experience and Management of Potential Risks

Date:           January 14-15, 2014

Location:    USP Meeting Center
                     12601 Twinbrook Parkway
                     Rockville, Maryland 20852

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Goals and Objectives:

  1. Review analytical science and methods for characterizing nanomaterials. Discuss their application to the characterization and quality control of drug products.
  2. Share experience and results using multiple formulation platforms for the same API: Effects on quality, safety, and efficacy of drug products containing nanosize constituents.
  3. Discuss approaches to the management of potential risks of nanomaterials in drug products starting from early drug development and throughout product lifecycle. The implication for maintaining quality, safety, and efficacy will be highlighted.
  4. Gather input regarding the considerations for utilizing nanotechnology in pharmaceutical products.
  5. Present experience and perspectives from international regulatory agencies and standards setting organizations on the use of nanotechnology in pharmaceutical products.
  6. Discuss areas where additional research on the effects of nanosize API on absorption, distribution, metabolism, elimination and toxicity may be needed. 

Expected Outcomes:

  • Establish opportunities for collaboration between academia, industry, and government sponsored research programs.
  • Develop a summary report of the workshop discussions and recommendations.


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