 |
Text only |
|
Department
of Dermatology
Ninewells
Hospital & Medical School, Dundee, DD1 9SY
|
|
 |
|
| Welcome | Courses | Research | Staff | Services | Resources for Current Students | |
|
|
|
Text only |
|
Department
of Dermatology
Ninewells
Hospital & Medical School, Dundee, DD1 9SY
|
|
|
|
| Welcome | Courses | Research | Staff | Services | Resources for Current Students | |
|
|
DRUG PHOTOTOXICITY
Abnormal photosensitivity of the human skin due to interaction between sun or an artificial light source and a therapeutic agent, has become of increasing importance in recent years, not only to patients but also to the Pharmaceutical Industry, research workers and Regulatory Authorities.
The problem for a new drug under development is to define the phototoxic potential and, if present, its essential characteristics.
Drug phototoxicity research has further developed over the past 10 years and the Unit has gained considerable expertise in the design, conduct and interpretation of phototoxicity clinical studies. Well equipped laboratory facilities allow a full complement of light/drug in vitro interaction studies to be conducted.
CLINICAL PHOTOTOXICITY TRIAL WORK
The Unit which has an extensive experience of serving industry, has concentrated on production of high quality clinical phototoxicity data. Using carefully controlled equipment and the simultaneous irradiation of volunteers allows such studies to be complete in eight weeks.
Where a new drug is considered to be a potential photosensitiser, the technique developed in Dundee is designed to answer a number of questions:
|
|
Is the drug in question photoactive or not? If so, what is the degree of photosensitivity, the wavelength dependency, the drug dosage relationship, the nature of the response and duration of susceptibility after stopping the drug. |
The study technique is conducted blind with placebo and a positive phototoxic comparator drug control. It is designed to provide the essential information on predicting whether there is a problem with a particular agent. It also provides information on the duration of photosensitivity following drug cessation, possible long term sequelae as well as advising on prevention techniques. A similar photopatch test technique for topical agents is available.
The Service: Advice is available on
|
|
Drug study design |
|
|
Protocols |
|
|
Case record forms |
|
|
Ethical approval submission |
|
|
Production of final reports |
When a drug is shown to be phototoxic, advice on how to protect, and even prevent this problem, is available.
Data from our monochromator/solar simulator study technique, which is conducted to Good Clinical/Laboratory Practice standards, is accepted by the Regulatory Authorities in Europe and North America.
Our established links with DDS Medicines Research Ltd (DDS), a contract pharmaceutical house on the Ninewells site, provides access to a full range of in house services which includes volunteer accommodation, often preferred for Phase 1 studies. DDS maintains a 36 bed clinical unit which is adjacent to a fully equipped pharmacokinetics laboratory.
Ninewells Hospital is an hour's drive from Edinburgh Airport and 2 hours from Glasgow Airport. There are daily flights between London City and Dundee Airport. By rail it is 6 hours from London. St Andrews, the home of golf, is half an hour across the Tay, and a short drive from the outstanding facilities at Gleneagles.
Professor James Ferguson, Director of the Unit, is a recognised expert in this field and would be pleased to discuss drug phototoxicity issues with you.
For further information contact:
Professor James Ferguson,
Consultant Photobiologist
Director, Photobiology Unit
Ninewells Hospital and Medical School
Dundee DD1 9SY, Scotland
Tel: 00 44 (0) 1382 632240
Fax: 00 44 (0) 1382 646047
e-mail: j.ferguson@dundee.ac.uk
|
|||||
|
Any enquiries to Prof J Ferguson: j.ferguson@dundee.ac.uk |
|
|
11/08/03 |
|
