title: [Reduction of animal experiments in experimental drug testing].
abstract: In order to ensure the quality of biomedical products, an experimental test for every single manufactured batch is required for many products. Especially in vaccine testing, animal experiments are traditionally used for this purpose. For example, efficacy is often determined via challenge experiments in laboratory animals. Safety tests of vaccine batches are also mostly performed using laboratory animals. However, many animal experiments have clear inherent disadvantages (low accuracy, questionable transferability to humans, unclear significance). Furthermore, for ethical reasons and animal welfare aspects animal experiments are also seen very critical by the public. Therefore, there is a strong trend towards replacing animal experiments with methods in which no animals are used ("replacement"). If a replacement is not possible, the required animal experiments should be improved in order to minimize the number of animals necessary ("reduction") and to reduce pain and suffering caused by the experiment to a minimum ("refinement"). This "3R concept" is meanwhile firmly established in legislature. In recent years many mandatory animal experiments have been replaced by alternative in vitro methods or improved according to the 3R principles; numerous alternative methods are currently under development. Nevertheless, the process from the development of a new method to its legal implementation takes a long time. Therefore, supplementary regulatory measures to facilitate validation and acceptance of new alternative methods could contribute to a faster and more consequent implementation of the 3R concept in the testing of biomedical products.
authors.affiliation: Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
authors.forename: H
authors.initials: H
authors.lastname: Behrensdorf-Nicol
authors.forename: B
authors.initials: B
authors.lastname: Krämer
mesh_terms: D000826:Animal Testing Alternatives / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000592:standards; D000827:Animal Welfare / Q000941:ethics / Q000331:legislation & jurisprudence*; D000818:Animals; D001681:Biological Assay / Q000941:ethics / Q000592:standards*; D004341:Drug Evaluation / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D005858:Germany; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations