Scale of health: indices of safety and efficacy in the evolving environment of large biological datasets.

Journal Article (Journal Article;Review)

The interdependent relationship between pharmacology and toxicology is fundamental to the concepts of efficacy and safety of both drugs and xenobiotics. The traditional concept of establishing efficacious and tolerated doses to define a 'therapeutic window' appears simplistic in the context of an exponentially increasing database on molecular mechanisms and cell biology that inform our understanding of homeostasis. Recent advances in nano medicine illustrate the convergence of efficacy and safety considerations that are central to establishing a clear pathway for regulatory review. The following overview considers biological responses to the administration of nanoparticles and the scale of balanced, within a range that might be considered 'normal', to unbalanced, abnormal responses associated with health and disease.

Full Text

Duke Authors

Cited Authors

  • Sayes, CM; Staats, H; Hickey, AJ

Published Date

  • September 2014

Published In

Volume / Issue

  • 31 / 9

Start / End Page

  • 2256 - 2265

PubMed ID

  • 24919930

Electronic International Standard Serial Number (EISSN)

  • 1573-904X

Digital Object Identifier (DOI)

  • 10.1007/s11095-014-1415-2


  • eng

Conference Location

  • United States