ALTEX :: Alternatives to Animal Experiments

1998, Supplement

Alternatives to Animal Experimentation: the Sophisticated Process of Validation

Michael Schwanig

Paul-Ehrlich-Institute, D-Langen

SUMMARY

The monographs of the European Pharmacopoeia (Ph.-Eur.) are legally binding. Namely in immunobiologicals there is still need to perform animal trials in testing for safety and potency. Only an alternative method which is introduced into the Ph.-Eur. is able to substantially reduce the number of animals. To introduce a new method into the Ph.-Eur., mainly to substitute the assay but also as part of the test- or in process-section of the monographs, the requirements of a formal follow-up have to be met. To understand these mechanisms, some of the underlying principles and the way a monograph is established are explained. To meet the requirements of a validated alternative method, the steps from the first idea to the request for revision are recapitulated. The development of such a method should be performed in close cooperation with the respective group of experts and the biological standardisation group of the Ph.-Eur. Some ideas for acceleration of the implementation are given.

Keywords: European Pharmacopoeia, monographs, revision, alternative methods, validation