title: [Alternatives to animal experimentation. The sophisticated process of validation]
abstract: 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 co-operation with the respective group of experts and the biological standardisation group of the Ph.-Eur. Some ideas for acceleration of the implementation are given.
authors.affiliation: Paul-Ehrlich-Institut, D-Langen.
authors.forename: Michael
authors.initials: M
authors.lastname: Schwanig