title: Alternatives to animals in the development and control of biological products for human and veterinary use. The role of the European Pharmacopoeia.
abstract: Since the adoption of the European Convention on animal protection the European Pharmacopoeia Commission has conducted a programme of work over the last decade directed at application of the Rs. The first stage of the work can be seen as phasing out animal tests which had become superfluous in current production conditions (for example, deletion of the abnormal toxicity test for vaccines and sera) and replacement of animal tests by in vitro methods (for example, replacement of bioassays of hormones by physico-chemical assays). Where deletion or replacement of tests is not possible, the scope for reduction of the number of animals used and the possibilities of refining the tests in ways that cause less suffering have to be considered. All these changes require extensive validation work and collaborative trials in a number of control laboratories to ensure that the quality standards are maintained with the alternative methods. From 1992 onwards, an extensive programme of biological standardisation has been carried out. For the progress made in pharmacopoeial standards to have its full effect, co-operation with the other interested parties (licensing and control authorities, animal welfare organisations, manufacturers) is essential. This should be seen by all concerned as an area for future efforts.
authors.affiliation: European Department for the Quality of Medicines, Council of Europe, Strasbourg, France.
authors.forename: A
authors.initials: A
authors.lastname: Artiges
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use; D005060:Europe; D006801:Humans; D010602:Pharmacopoeias as Topic; D014612:Vaccines / Q000592:standards
chemical_list: D001688:Biological Products; D014612:Vaccines