Animal tests in pharmacopoeia monographs. Current state and possibilities for improvements

The German pharmacopoeia contains many monographs on sera and vaccines which require animal tests. Large numbers of animals are used and very often suffering is extreme. Considering animal welfare many of these animal tests may be improved. This study gives examples that the number of animals might be reduced and the test systems refined only by harmonisation of existing requirements which use different animal numbers or experimental design for comparable procedures.