Scientific and Regulatory Policy Committee (SRPC) Review*:Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment

Charles E. Wood, Renee R. Hukkanen, Radhakrishna Sura, David Jacobson-Kram, Thomas Nolte, Marielle Odin, Samuel M. Cohen

Research output: Contribution to journalArticle

30 Scopus citations


Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardization of proliferation assays will become an increasingly important part of cancer risk assessment. To help address this development, we also discuss the potential role for proliferation data as a component of alternative carcinogenicity testing models. This information should improve consistency of cell proliferation methods and increase efficiency of targeted testing strategies.

Original languageEnglish (US)
Pages (from-to)760-775
Number of pages16
JournalToxicologic Pathology
Issue number6
StatePublished - Aug 2015



  • BrdU
  • Ki-67
  • PCNA
  • carcinogenesis
  • cell proliferation
  • mode of action

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Biology
  • Toxicology
  • Cell Biology

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