Q: What key factors are necessary to develop practical, safe and effective nanomedicines?
As with any medicine, an understanding of the critical product attributes that govern safety and efficacy is vitally important,
as well as the ability to ensure characterisation of these parameters using validated analytical techniques. With nanomedicines,
it is also important to consider the route of administration, dose, frequency of administration, fate of the nanomaterial
(all components from the product), any detrimental bioactivity, antigenicity, immunogenicity and haematocompatibility.
As nano-sized medicines often display very different pharmacokinetics and body distribution compared with low-molecular chemical
entities at the whole body and cellular level, the pharmacokinetics–pharmacodynamics relationship needs to be carefully considered
during the establishment of critical product attributes relating to safety and efficacy. For each product, it is also essential
to consider the proposed clinical setting for use.
Ruth Duncan is Professor Emerita at Cardiff University (UK), and visiting professor at CIPF (Spain) and the University of Greenwich (UK).
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3. R.A. Petros and J.M. DeSimone, Rev. Drug Discov., 9(8), 615–627 (2010).