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Perspectives for Characterizing Drug Component of Theranostic Products Containing Nanomaterials

  • Christie M. SayesEmail author
  • Anthony J. Hickey
Chapter
Part of the Bioanalysis book series (BIOANALYSIS, volume 5)

Abstract

Drug products containing engineered nanomaterials provide unique therapeutic opportunities. However, because this field of research and development is rapidly changing, nanomaterial drug products present multiple regulatory challenges. This book chapter summarizes the evolving field of nanotheranostics by exploring the crucial factors that require a multidisciplinary strategy to reach drug safety and efficacy. This includes a brief overview of the United States Pharmacopeia, which recommends standards for drug products and coordinates efforts with the US Food and Drug Administration to ensure the quality of nanomaterial drug products. Lastly, with the safety of human health as a clear target, this chapter reviews manufacturing and analytical considerations that allow for constancy and control of novel drug products.

Keywords

Manufacturing Quality Regulatory Efficacy Therapeutic Health Human health Drug Safety Drug safety Drug products Agents Development Nanomaterial Theranostic Pharmaceutical Manufacturing considerations Analytical considerations Personalized medicine Critical quality attributes Quality by design United States Pharmacopeia Food and Drug Administration Economic drivers Cancer Databases 

Notes

Acknowledgments

CS thanks Baylor University for resources needed to write this chapter.

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Copyright information

© This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2019

Authors and Affiliations

  1. 1.Department of Environmental ScienceBaylor UniversityWacoUSA
  2. 2.RTI InternationalResearch Triangle ParkUSA

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