Our Services
Pharmaceutical
Drug phototoxicity is defined as an abnormal sensitivity of the skin to
sunlight or artificial light sources due to interaction between
photons and a therapeutic agent within the skin. It is non
immunologically based and can arise in any individual
providing there is enough of the drug and appropriate radiation
to cause the problem. The skin manifestations are varied
with swelling, redness, blistering, pigmentation,
accelerated skin ageing and on rare occasions skin cancer.
This issue has become
increasing important to patients, regulatory authorities
and the pharmaceutical
industry. Photosafety regulatory guidelines were introduced
earlier this decade from
Europe and the USA. Individual drug issues are assessed on
a case by case basis
with a significant element of flexibility as to laboratory
and clinical studies considered
to be necessary.
Professor James Ferguson has developed an
evidence based methodology for studying phototoxicity in
clinical volunteers. Over the years a substantial expertise
in considering the need or otherwise for such work has been
established Clinical phototoxicity trials are conducted on
healthy volunteers using the drugs
or product supplied by industry and tested for phototoxicity.
The results will be
analysed and reported back to the trial sponsor.
Phototoxicity testing is carried out on the premises of the
National Photobiology Unit,
Ninewells Hospital and Medical School (part of NHS Tayside).
Full phototoxicity services comprise:
- Volunteer phototoxicity studies for topical and systemic drugs
- Laboratory
phototoxicity and photogenotoxicity testing
- Scientific input
- Study design
- Protocol production and review (in collaboration
with sponsor)
- Ethics submission and approval
- Regulatory approval (if necessary)
- CRF design
- IMP management
- Subject recruitment and consent
- Dosing and sampling
- Phototesting and recording of results
- Accident and Emergency
management
- Monitoring and Q&A
- Data management
- Interpretation of results
- Report production and review
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