Abstract
It is a requirement as part of the safety evaluation of novel compounds, which are intended to be administered to pregnant women or women with young children, that the potential for the compound or its metabolites to be transferred from a dam to its litter during lactation is measured. The data obtained from the rat milking studies are also used to support the rat peri- and post-natal studies. Therefore it is necessary to collect multiple milk samples from lactating rats. In this paper it was decided to concentrate on three areas: 1. The factors which had to be considered during the development of the rat milking technique; 2. The outline of the basic study design for a rat milking study; 3. The technique for milking rats.