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 Monroe Cohen

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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
Volume43
Issue number6
DOIs
StatePublished - Aug 2015

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Cell proliferation
Advisory Committees
Risk assessment
Cell Proliferation
Assays
Neoplasms
Testing
Quality Control
Carcinogens
Standardization
Quality control
Reference Values
Pharmaceutical Preparations

Keywords

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

ASJC Scopus subject areas

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

Cite this

Scientific and Regulatory Policy Committee (SRPC) Review*:Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment. / Wood, Charles E.; Hukkanen, Renee R.; Sura, Radhakrishna; Jacobson-Kram, David; Nolte, Thomas; Odin, Marielle; Cohen, Samuel Monroe.

In: Toxicologic Pathology, Vol. 43, No. 6, 08.2015, p. 760-775.

Research output: Contribution to journalArticle

Wood, Charles E. ; Hukkanen, Renee R. ; Sura, Radhakrishna ; Jacobson-Kram, David ; Nolte, Thomas ; Odin, Marielle ; Cohen, Samuel Monroe. / Scientific and Regulatory Policy Committee (SRPC) Review*:Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment. In: Toxicologic Pathology. 2015 ; Vol. 43, No. 6. pp. 760-775.
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