Nanopharmaceuticals: Challenges and Regulatory Perspective

  • Rakhi B. Shah
  • Mansoor A. Khan
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume X)



Products in nanometer size range offer “uniqueness” because of their altered properties as compared to their macro-counterparts. Improved solubility, permeability, or targetability of nanoparticles seems to be beneficial in the drug delivery area. As an example, “nano” paclitaxel molecules may reach a tumor cell line sooner than the “bulk” paclitaxel. Similarly, if a nanodrug is unable to reach a particular receptor, specialized nanoparticles have been proven to have the ability to reach that receptor (Dubey, 2006). Therefore, there is a lot of interest in using a nanotechnology platform to deliver drugs, and it explains the spurt in funding for nanotechnology research.

The research and development funding for nanotechnology from government and industry is estimated at nearly US$10 billion globally for 2005 (Lux research, 2006). By 2014, it is estimated that the global value of nanotechnology products will exceed US$2.5 trillion (Lux research, 2004). After formation of...


National Nanotechnology Initiative Nanotechnology Product Supercritical Fluid Technology Biological License Application Micrometer Size Range 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.




Absorption, distribution, metabolism, and elimination


Atomic force microscopy


Abbreviated New Drug Application


Asia Nano Forum


American Standards for Testing and Materials


Active pharmaceutical ingredient


Biopharmaceutical Classification System


Biological Licensing Application


Center for Biological Evaluations and Research


Center for Drug Evaluation and Research


Center for Device and Radiological Health


Code of Federal Registrar


Chemistry, manufacturing, and control


Center for Responsible Nanotechnology


Council for Science and Technology (United Kingdom)


Center for Technology Assessment


Center for Veterinary Medicine


Deoxyribonucleic acid


Environmental Protection Agency


Food and Drug Administration

FD&C act

Food, Drug and Cosmetic Act


Friends of Earth


Generally regarded as safe


International Conference on Harmonization


International Council on Nanotechnology


International Center for Technology Assessment


Inactive Ingredient Guide




Medicines and Healthcare Products Regulatory Agency (United Kingdom)


Magnetic resonance imaging


National Characterization Laboratory


National Cancer Institute


New Drug Application


National Institute of Standards and Technology


National Nanotechnology Initiative


National Strategy for Combating Terrorism


Office of Regulatory Affairs


Office of Science and Health Coordination






Process analytical technology


Particle size distributionh


Quality by Design


Research and Development




Self-emulsifying drug delivery systems


Self-nano-emulsifying drug delivery systems


United States Code




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Copyright information

© American Association of Pharmaceutical Scientists 2009

Authors and Affiliations

  • Rakhi B. Shah
    • 1
  • Mansoor A. Khan
    • 2
  1. 1.Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Sciences, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver springUSA
  2. 2.Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Sciences, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver springUSA

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