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History and Current Regulatory Requirements

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Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

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Abstract

The assessment of risk to humans of cancer following exposure to chemicals has been a challenging process for decades. The early pragmatic approaches to this important challenge have evolved with growing understanding of the underlying biology of the cellular processes that lead to tumor development in animals and the relevance of these findings to human risk. The regulatory approaches to assessment of human risk of cancer in place today reflect the current state of understanding of these complex biological processes while providing a common regulatory framework for risk assessment. This chapter reviews the evolution of this process from the early days to the current state setting the framework for further evolution of how we address this critical challenge.

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Author information

Authors and Affiliations

  1. Synergy Partners R&D Solutions, LLC, 385 Route 24, Suite 1G, Chester, NJ, 07930, USA

    James S. MacDonald

  2. ToxRox Consulting, McLean, VA, USA

    David Jacobson-Kram

Authors
  1. James S. MacDonald
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  2. David Jacobson-Kram
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Corresponding author

Correspondence to James S. MacDonald .

Editor information

Editors and Affiliations

  1. Vice- President of Drug Safety Evaluation, Bristol-Myers Squibb, Princeton, New Jersey, USA

    Michael J. Graziano

  2. ToxRox Consulting, McLean VA 22101, Virginia, USA

    David Jacobson-Kram

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MacDonald, J.S., Jacobson-Kram, D. (2015). History and Current Regulatory Requirements. In: Graziano, M., Jacobson-Kram, D. (eds) Genotoxicity and Carcinogenicity Testing of Pharmaceuticals. Springer, Cham. https://doi.org/10.1007/978-3-319-22084-0_6

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