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Future Direction
Phototoxicology Studies
The NCTR Center for Phototoxicology / NTP Center for Phototoxicology
(NCP) was created to meet the phototoxicology and photocarcinogenesis
research and testing needs of both the
FDA and the
NTP. In this
leadership role, the NCP will continue to provide important scientific
information needed for risk assessment and risk management decisions. In
addition, the NCP will be a resource for other federal research and
regulatory agencies thereby providing guidance and giving advice on
issues involving photo-irradiation and phototoxicology (e.g., potential
risk from chemical and UV exposure; design and execution of
phototoxicology studies, etc.).
FDA Mission and NTP Vision/Roadmap Support
The NCP is located at the FDA's
National Center for Toxicology
Research (NCTR). FDA’s primary mission is to promote and protect the
health of the American public and NCTR supports that mission by
providing high quality scientific data to FDA’s regulatory product
centers. As the NTP and its partners implement the NTP Roadmap to
achieve the NTP vision’s for the 21st century (http://www.ntp.gov), the
NCP will support the NTP Roadmap by developing and applying new
mechanistic toxicology tools by which to identify biomarkers predictive
of toxic or carcinogenic events prior to the phenotypic expression of
those events. Creating, validating and understanding how this new type
of scientific information can be used in regulatory decision making will
be a priority for the NCP.
Evolution of Phototoxicology
There are many aspects of phototoxicology and photocarcinogenesis
where new advances in biochemical techniques can enhance the information
gained from a study, or result in a change in study design. As an
example, the NCP is examining the utility of digital photography in
documenting clinical observations in the test animals and as an
instrument for measuring skin changes. Another example is examination of
genomic changes as predictive biomarkers for skin cancer development. In
addition, the NCP is currently evaluating various statistical methods by
which tumor multiplicity can be factored into result interpretation and
also developing computer modeling programs which predict skin tumor
growth and growth patterns. The NCP will continue to provide leadership
by advancing the science of phototoxicology.
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2006-JAN-23.