Comparative pyrogen reactivity of rabbit and man to human albumin and immunoglobulin solutions.
According to the prescriptions of the Hungarian Pharmacopoeia regarding the pyrogenicity of human albumin and immunoglobulin solutions, the temperature increase should not exceed 0.5 degrees C in rabbits. If the average rise in temperature of rabbits is between 0.6 to 1.1 degrees C, the preparation--in other respects meeting the requirements--can be tested in man (generally 20 persons per preparation). Products causing an average rise in temperature less than 0.6 degrees C and provoking individual rises of temperature below 1 degrees C in man, can be issued. On the basis of these data going back for many years, no reliable correlation could be found between the pyrogen test in rabbits and temperature rise in man. The same preparation which failed to pass the rabbit pyrogen test proved to be apyrogenic in man.
D000418:Albumins / Q000633:toxicity*; D000818:Animals; D001681:Biological Assay; D002648:Child; D004340:Drug Contamination; D005334:Fever / Q000139:chemically induced*; D006801:Humans; D007136:Immunoglobulins / Q000633:toxicity*; D011749:Pyrogens; D011817:Rabbits; D013045:Species Specificity
D000418:Albumins; D007136:Immunoglobulins; D011749:Pyrogens