Dose calculations for medical research applications

The Radionuclide Effects Group and the Internal Dosimetry Group at the HPA Radiation Protection Division, Chilton, jointly provide a dose calculation service to pharmaceutical companies and associated laboratories wishing to administer radiolabelled compounds to volunteers as part of their drug research programmes. The dose calculations are necessary for the preparation of submissions to ARSAC by the pharmaceutical companies for prior authorisation and certification to expose human volunteers for medical research purposes, in accordance with the Medicines (Administration of Radioactive Substances) Regulations 1978.

The companies provide NRPB with data from animal experiments on the tissue distribution, retention and excretion of the ¹⁴C or ³H labelled materials. These are used to estimate likely effective doses to human volunteers, using dose calculation methodologies established by the International Commission on Radiological Protection ( ICRP).

Last reviewed: 13 August 2009