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Scale of Health: Indices of Safety and Efficacy in the Evolving Environment of Large Biological Datasets

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Abstract

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.

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Acknowledgments and Disclosures

CMS would like to thank the CDC National Institute for Occupational Safety and Health (NIOSH) and AJH would like to thank the National Institutes of Health (NIH) and the Nanomaterial Registry (www.nanomaterialregistry.org/) for financial support.

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Authors and Affiliations

  1. Technology for Industry and the Environment, RTI International, 3040 Cornwallis Rd, Durham, NC, 27709, United States of America

    Christie M. Sayes & Anthony J. Hickey

  2. Department of Pathology, Duke University Medical Center, 27710, Durham, NC, United States of America

    Herman Staats

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  1. Christie M. Sayes
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  2. Herman Staats
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  3. Anthony J. Hickey
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Correspondence to Anthony J. Hickey.

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Sayes, C.M., Staats, H. & Hickey, A.J. Scale of Health: Indices of Safety and Efficacy in the Evolving Environment of Large Biological Datasets. Pharm Res 31, 2256–2265 (2014). https://doi.org/10.1007/s11095-014-1415-2

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  • DOI: https://doi.org/10.1007/s11095-014-1415-2

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