Animal Models of Human Diseases – scientific and regulatory approachs

Animal Models of Human Diseases – scientific and regulatory approachs

Oral presentation

Enriko Aleksiev
Faculty of Chemistry and Pharmacy, University of Sofia “St. Kliment Ohridski”, Sofia

Animal models are classic pharmacological models and are used as a mandatory element in preclinical (toxicological and pharmacological) trials of new medicinal products. Classical pharmacological studies include sequential testing of new substances of human, animal, plant or chemical origin on isolated organs, followed by experiments in animals, particularly rats and mice, but also in higher animal species. Approaches using experimental animals are characterized with relatively high relevance, and animal models derived from animals are extrapolated to humans. In recent years, the substitution of animal and animal models with in vitro models has been increasingly embedded in practice, but some of the studies are mandatory in modern guides for preclinical pharmacotoxicology.