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This document discusses the requirement and practical application of testing for pyrogens in vaccines and immunoglobulins. It summarizes data on the number of rabbits used for pyrogenicity testing of meningococcal and pneumococcal vaccines in Germany from 1991-1993. It finds that a total of 60 rabbits were used to test vaccine batches, and an additional 45 rabbits were used for in-process testing. For immunoglobulins, an estimated minimum of 4650 rabbits were used for batch testing over that period. The doc

Author

Anjali Mohan

Language

EN