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

Abstract

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. The aim is to encourage institutions, public authorities, and the pharmaceutical industry to investigate the importance and the necessity of the remaining tests. In addition, all parties should be encouraged to initiate integrated projects to develop, validate and establish alternative methods.