Abstract: There is a continuing need for increased throughput in the examination of new chemical entities (NCEs) in terms of the pharmacokinetic (PK) parameters. The aim was to validate a new study method which allows a higher throughput, the examination of inter-animal variability and a reduction in the numbers of animals needed for routine bioavailability studies of NCEs in awake rats. The design uses a new method for intravenous (iv) administration via the saphenous vein in combination with serial blood sampling via the tail vein. The multiple sampling method was compared with single sampling (decapitation) and the effect on haematocrit (Hct) levels was studied. Direct injection in the saphenous vein was compared to iv administration using an indwelling jugular catheter. Using structural different CE's, it was shown that a combination of direct injection via the saphenous vein and multiple sampling from the tail vein produces comparable plasma concentrations and subsequent PK results to the comparator methods.

Abstract: Animal model to measure visceral pain of a balloon catheter and an implantable sensor module having transcutaneous telemetring ability. The implantable sensor module is set up to receive both visceromotor and pseudoaffective responses of the test animal. In particular, the balloon catheter is an implantable balloon catheter, preferably implanted in the duodenum of the test animal and the implantable sensor is set up to receive input signals form at least one bipolar electrode pair and at least one blood catheter. A method for producing said animal as well as kits comprising a balloon catheter and an implantable sensor module for use in a method for producing said animals are also described.