We are very experienced working with organisations involved in the preparation of clinical trials of pharmaceuticals. Whether you're a small energetic start-up or an industry leader, expect a fast, efficient and very supportive service.
Following preclinical trials where data is obtained for the distribution and retention of a radiolabelled test substance, approval must be sought to proceed to the clinical phase. We provide a full report giving estimates of equivalent doses to organs and the effective dose to a human volunteer, suitable for submission as part of such an application both in the UK and internationally.
What data is needed?
Applications should include estimates of effective dose based on the best information available at the time. Where such estimates are not possible from similar existing human studies, data from animal biokinetics studies, or from human biokinetics studies involving extremely low radiation doses, can be submitted as part of the application. The activity administered to individuals should be the minimum consistent with obtaining adequate information, especially for administrations to volunteers who are not expected to benefit directly.
Full test substance assessment
Our Dose Calculation Service provides a full assessment of the effective dose and equivalent doses to organs to a patient or volunteer following administration of the test substance. We also provide an estimate of the maximum amount of radioactivity, specific to the test substance, which could be administered without exceeding the recommended effective dose to the individual as advised by the World Health Organization (WHO) (1977) and the International Commission on Radiological Protection (ICRP) (1992) based on the categories of risk and corresponding benefit for human exposure in biomedical research.