Requirements for the Preclinical Pharmacology and Safety Assessment

This section mainly addresses the purpose and technical aspects of preclinical studies which are described and recommended in the registration guidelines of the EEC, Japan and the USA. The following brief descriptions of commonly used test procedures cannot replace the detailed study of guidelines by those who conduct these trials. They are intended to give the less experienced an idea about the safety standards, which have to be fulfilled by a medicinal product and about the purpose and conduct of these tests. This enables scientists in research and development to judge essential parts of a project for themselves and to make better and informed decisions. It also assists in planning time and cost of a project. 

Attempts are underway to harmonize guidelines for preclinical test procedures in the EEC, Japan and USA in order to avoid the unnecessary duplication of animal tests due to different formal requirements. Other countries will adopt such common 

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