Data should be provided from pre-clinical ADME studies in pigmented animals, for as many of the organs and tissues with specific weighting factors as possible, bearing in mind the following comments:

• Data should also be provided on urinary and faecal excretion. Doses to the gastrointestinal tract (GI tract) from radionuclides in the contents will be calculated from the ICRP Publication 30 GI tract model, taking into account the excretion data. If data for retention in the GI tract wall are provided, this contribution to the dose to the GI tract will be calculated separately. The dose to the colon is taken to be the mass weighted mean of the dose to the lower and upper intestine. Although the oesophagus is a listed tissue, the International Commission on Radiological Protection (ICRP) Publication 30 model does not consider doses to it and the thymus is used as a surrogate.
• The dose to bone surfaces includes a contribution from activity in the red bone marrow.
• The eye is not included in the list of remainder organs by ICRP but is included in dose calculations for radiopharmaceuticals because of the possibility of melanin binding leading to high concentrations in the choroid.
• Organ and tissue retention data should preferably be submitted as % administered activity per organ or tissue. If this is not available then the animals' bodyweights should be included to allow for conversion of the data from microgram equivalents per organ or tissue using standard organ and tissue weights. Urinary and faecal excretion data should be submitted as % administered activity excreted over the time period measured.

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