Search

[B28 Asp]-human insulin (insulin aspart, CAS 116094-23-6, X14) is a rapidly absorbed analogue of human insulin currently undergoing development for the treatment of diabetes mellitus. Cardiovascular studies and a range of standard behavioural, neurological and organ function tests were conducted in various animal species to investigate potential secondary pharmacological effects of insulin aspart. Single intravenous injections (to ensure maximum bioavailability) of a range of doses of insulin aspart were compared with a soluble human insulin preparation. The validity of the test systems was always tested with appropriate positive and/or negative (vehicle) control compounds. Secondary effects due to hypoglycaemia were identified by simultaneous administration of a glucose solution along with the highest dose of insulin aspart and the vehicle as negative control. No safety issues were raised by these experiments; insulin aspart and soluble human insulin exhibited similar pharmacological profiles throughout.

An indirect immunofluorescence technique employing rubella virus infected SIRC-cells grown in flat-bottomed plastic plates is described for the detection of specific IgM-class rubella antibodies in serum fractions obtained by sucrose density ultracentrifugation. The results were read by means of a fluorescence microscope with an incident light illuminator. A total of 176 serum specimens from five groups of patients were used for determination of the specificity and sensitivity of the test. The technique proved to be less time consuming and in addition to be more sensitive than the hemagglutination-inhibition method for the detection of rubella IgM-class antibodies.