[The development and approval of alternative methods to bioassays used for quality assurance, a challenge for the pharmaceutical industry and the authorities].

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.

Possibilities of replacing and reducing animal tests in the pharmacopoeias: an evaluation of unused methods and proposals for change.

The animal tests currently carried out according to the German and European pharmacopoeias are evaluated. The routine testing of biological medicines, excluding vaccines and pyrogen tests, is examined. The opportunities for replacing obligatory bioassays and safety tests are assessed, taking into account both pharmaceutical quality and animal welfare aspects.