The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
View this resource Bookmark this resourcePreclinical Studies
In this section you may find relevant information regarding the safety, efficacy and toxicology of the drugs actually used for Rare Diseases as well as:
Good Laboratory Practices (GLPs),
Animal models: juvenile, humanised animal models, disease specific animal models and documents that may support you to correctly use animal models from ethical points of view.
Proof of principle
In silico modelling
