title: [The development and approval of alternative methods to bioassays used for quality assurance, a challenge for the pharmaceutical industry and the authorities].
abstract: Bioassays are performed to ensure a constant quality of medicines derived from biological sources. These tests are stipulated for some drugs in the German and European Pharmacopoeias. They are justified because physico-chemical or other analytical methods may not be appropriate to define exactly the potency of the drug in each individual batch and/or to detect any biologically relevant impurities. However, the implementation of good manufacturing practice and the technological progress in manufacturing and in analytical methods in the last few years raise the question whether some traditional bioassays can be replaced by new alternative methods which do not require biological tissues or animals. With respect to this topic the pharmacopoeias were reviewed and some proposals are presented in this paper. However, these approaches can only be realised when all parties involved - pharmaceutical industry, regulatory authorities and others - co-operate in the challenge to replace - wherever possible - bioassays by appropriate alternative methods.
authors.affiliation: Stiftung zur Förderung der Erforschung von Ersatz- und Ergänzungsmethoden zur Einschränkung von Tierversuchen (SET), D-Mainz, Germany.
authors.forename: Gundel
authors.initials: G
authors.lastname: Miethe
authors.forename: Gisbert
authors.initials: G
authors.lastname: Sponer
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence / Q000592:standards*; D001681:Biological Assay / Q000379:methods; D004345:Drug Industry / Q000592:standards; D005858:Germany; D011785:Quality Assurance, Health Care