Interpretation of animal data in the calculation of doses from new radiolabelled compounds

The Radionuclide Biokinetics Group of the Biomedical Effects Department at NRPB provides a dose calculation service for pharmaceutical companies and associated laboratories which plan to administer radiolabelled drugs to human volunteers as part of their research and development programmes for new compounds. Animal data provided by these companies are used to estimate the likely doses to humans from administration of the compound. The dose estimate then accompanies the pharmaceutical company's application for approval from the UK Administration of Radioactive Substances Advisory Committee (ARSAC). The method of calculation, the interpretation of the animal data and the range of results obtained are discussed. In addition, the effect of the use of the new ICRP tissue weighting factors in the calculations is considered. (Author)