title: [Animal experiments in the context of quality control of pharmaceuticals. Review of the European Pharmacopoeia, 4th edition, 2002].
abstract: In the 4th edition of the European Pharmacopoeia, animal experiments are described, which are required for the quality control of pharmaceuticals. This refers to investigations regarding both biological activity and safety aspects of the medication. The latter include investigations to find contaminations with histamine and pyrogenic substances and tests for abnormal toxicity. Even though the safety of medical drugs is of great importance, it should be examined whether these tests are still indispensable (in terms of paragraph sign 7 of the German Animal Protection Law of 2002). The determination of histamine content may also be possible by chemical-analytical methods, which could represent an alternative to the animal experiment. The testing of abnormal toxicity should be scientifically questioned due to its lack of specificity. Although the in vitro test detecting bacterial endotoxins is mentioned in many monographs, the in vivo test on rabbits to test for pyrogenicity is still mentioned in some other monographs. The in vivo test should be rechallenged as to whether it can be replaced. In light of the global trade in pharmaceuticals, which must also fulfill national quality standards a reduction in animal experiments can only be reached by fruitful cooperation between pharmaceutical companies, health authorities and the commissions of the pharmacopoeias, leading to the formation of a consensus. The International Conference on Harmonization could prove an auspicious panel to take up this subject and to contribute to an internationally accepted and scientifically based reduction of animal experiments.
authors.affiliation: Stiftung zur Foerderung der Erforschung von Ersatz- und Ergaenzungsmethoden zur Einschraenkung von Tierversuchen, D-Mainz.
authors.forename: Gisbert
authors.initials: G
authors.lastname: Sponer
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D000830:Animals, Laboratory; D001681:Biological Assay; D005060:Europe; D006632:Histamine / Q000032:analysis; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical
chemical_list: D004364:Pharmaceutical Preparations; D006632:Histamine