Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Non-human primates in research and safety testing

Katharina Illgen (Abschlußjahr: 2015)

Summary
Language: English
In the European Union, about 12 million animals were involved in scientific operations within the Member States of the European Union in 2011 while the number of non-human primates amounts to about 6 000, especially old world monkeys, new world monkeys and apes. Non-human primates are still understood as an essential prerequisite for the research and development of medicinal products and devices, as they are involved in safety testing of pharmaceuticals and devices as well as in fundamental biology research.
Research involving non-human primates must be composed, conducted and verified in accordance with binding legal and regulatory requirements, whereas especially the principles of the Three Rs: replacement, reduction and refinement have to be faithfully respected.
The adoption of EU Directive 86/609/EEC (replaced by Directive 2010/63/EU in 2013) on the protection of animals used for experimental and other scientific purposes resulted in an improvement of the establishment of a controlled use of animals included in experimental methods and furthermore lead to harmonized procedures within the EU. The vision of this first adopted EU Directive is to encourage and support the continuous strive for the development and introduction of innovative alternative methods that have the goal to replace the use of animals in research.
An important aspect to be conceived is to respect and constantly improve the animal’s welfare by considering the animal’s physical as well as social needs.
Due to a constantly changing and improving scientific environment several approaches are meanwhile promising to show scientific evidence to be of importance for the support of the targeted discontinuance of the use of non-human primates for research purposes.
This Master thesis reflects on certain areas of research and safety testing involving non-human primates and thereby provides an overview of the legal and regulatory requirements, describes the approaches that scientifically justify their involvement and as an important matter that goes along with the inclusion of non-human primates conceives ethical considerations as well as emphasizes the need to ensure animals welfare. Furthermore, an outlook on currently discussed alternative approaches likely to be considered as replacement strategies for the use of non-human primates is given.
Pages total: 47, Annex pages: 1