LONDON, Feb. 28, 2011 /PRNewswire/ — The staffs of Chiltern
International Limited (Chiltern), a global contract research
organization (CRO), and Spectratox Limited, celebrate the 25 year
mark of their successful collaboration in Drug Phototoxicity.
Chiltern Early Phase and Spectratox have worked together using a
validated and regulatory accepted in vivo human study method
for the assessment of drug phototoxicity. The history of this
collaboration can be traced through their multiple publications in
peer reviewed journals.
“The success story of this methodology is not just measured in
publications,” stated Dr Brian Sanderson, Medical
Director, Chiltern Early Phase. “It is measured in the success we
have had in helping new drugs continue their developmental journey
for areas of therapeutic need.”
Professor James Ferguson, Head of the Academic Department
of Dermatology, University of Dundee, and CEO of Spectratox,
explained, “The evolution of randomized controlled trials has been
in response to industry and regulatory requirements. Our trials,
which tend to be conducted prior to Phase 3, produce data that
defines the phototoxic risk in man in terms of severity and causal
wavelengths as well as providing an understanding of the likelihood
of ocular phototoxicity. Where phototoxicity is found, advice on
protective measures to enable future development of the compound is
an important aspect of our work.”
Dr Sanderson added, “New study designs have been introduced to
act as initial “screening” in man for drugs with potential phototoxicity.
The new designs have evolved in response to the growing demand to
assess this earlier in clinical drug development. The benefits are
savings in both time and cost whilst remaining scientifically
robust.”
Glenn Kerkhof, Chiltern CEO, commented, “This 25 year
collaboration is cause for celebr
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