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Discover Toxicology: An Early Safety Assessment Approach

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Translating Molecules into Medicines

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 25))

Abstract

Early safety assessment efforts from target identification to lead development have undergone rapid growth and evolution over the last 10 years. In this chapter, we will discuss the current development trends driving the need for early safety assessment practices. We will discuss the key areas of focus which include target-related, off-target-related, and chemical property-related toxicities. We will offer an overview of the various scientific approaches being utilized in each of these focus areas along with an organizational framework that has proven effective in de-risking the early portfolio. We will conclude with some perspectives on application within the project team setting and traps associated with data over interpretation.

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Authors and Affiliations

  1. Department of Investigative Toxicology, Lilly Research Labs, Eli Lilly and Company Lilly Corporate Center, Indianapolis, IN, 46285, USA

    Thomas K. Baker, Steven K. Engle, Bartley W. Halstead, Brianna M. Paisley, George H. Searfoss & Jeffrey A. Willy

Authors
  1. Thomas K. Baker
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  2. Steven K. Engle
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  3. Bartley W. Halstead
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  4. Brianna M. Paisley
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  5. George H. Searfoss
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  6. Jeffrey A. Willy
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Corresponding author

Correspondence to Thomas K. Baker .

Editor information

Editors and Affiliations

  1. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    Shobha N. Bhattachar

  2. Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Wallingford, Connecticut, USA

    John S. Morrison

  3. ADME, Drug Disposition, Eli Lilly and Company, Indianapolis, Indiana, USA

    Daniel R. Mudra

  4. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    David M. Bender

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© 2017 American Association of Pharmaceutical Scientists

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Baker, T.K., Engle, S.K., Halstead, B.W., Paisley, B.M., Searfoss, G.H., Willy, J.A. (2017). Discover Toxicology: An Early Safety Assessment Approach. In: Bhattachar, S., Morrison, J., Mudra, D., Bender, D. (eds) Translating Molecules into Medicines. AAPS Advances in the Pharmaceutical Sciences Series, vol 25. Springer, Cham. https://doi.org/10.1007/978-3-319-50042-3_5

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