Standardized protocols for photocarcinogenesis safety testing

P. Donald Forbes, Janusz Z. Beer, Homer S. Black, Jean Pierre Cesarini, Curtis A. Cole, Ronald E. Davies, John M. Davitt, Frank DeGruijl, John Epstein, Anny Fourtanier, Adèle Green, Thomas Koval, Ronald D. Ley, Romano Mascotto, Warwick Morison, Robert Osterberg, David Sliney, Frederick Urbach, Jan C. Van Der Leun, Antony R. Young

Research output: Contribution to journalArticle

Abstract

Solar ultraviolet radiation (UVR) is recognized as a major cause of non-melanoma skin cancer in man. Skin cancer occurs most frequently in the most heavily exposed areas and correlates with degree of outdoor exposure. The incidence of skin cancer is also increased by contact with photosensitizing drugs and chemicals such as psoralens, coal tars and petroleum stocks. Other substances which do not act as photosensitizers, such as immunosuppressants taken by organ transplant recipients, also increase the risk of skin cancer. The U.S. Food and Drug Administration requests, on a case-by-case basis, that risk of enhanced photocarcinogenesis is assessed for many classes of drugs. Health Canada's Therapeutic Products Programme has issued a Notice of Intent to regulate pharmaceutical products which may enhance carcinogenicity of the skin induced by ultraviolet radiation. Other national regulatory agencies review such data when they exist, but their own requirements emphasize batteries of short-term in vitro and in vivo tests. While they may support drug development strategies, short-term tests have yet to be validated as predictors of the ability of drugs or chemicals to enhance photocarcinogenesis. Published protocols now describe study designs and procedures capable of determining whether test agents enhance the rate of formation of UVR-induced skin tumors.

Original languageEnglish (US)
JournalFrontiers in bioscience : a journal and virtual library
Volume8
StatePublished - 2003
Externally publishedYes

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Keywords

  • Guidelines
  • Laboratory Models
  • Photocarcinogenesis
  • Protocols
  • Review
  • Safety Testing
  • Toxicology
  • Uv Radiation

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Biochemistry
  • Cell Biology

Cite this

Forbes, P. D., Beer, J. Z., Black, H. S., Cesarini, J. P., Cole, C. A., Davies, R. E., Davitt, J. M., DeGruijl, F., Epstein, J., Fourtanier, A., Green, A., Koval, T., Ley, R. D., Mascotto, R., Morison, W., Osterberg, R., Sliney, D., Urbach, F., Van Der Leun, J. C., & Young, A. R. (2003). Standardized protocols for photocarcinogenesis safety testing. Frontiers in bioscience : a journal and virtual library, 8.