The course aims to describe the nature and mechanisms that characterize the adverse effects related to different biotechnology-derived products: biological medicinal products, diagnostic products and food supplements
Course Prerequisites
The course represents a toxicological training, in particular related to biotechnology products, for students in Advanced Biotechnology. No particular requirements are necessary
Teaching Methods
Lessons will be combined with seminars on specific topics of relevance for the course
Assessment Methods
Oral examination aiming to evaluate the toxicological skills acquired in relation to the contents of the course. The final mark will focus on the level of understanding and of oral exposure of the topics
Texts
Slides provided by the lecturer.
Casarett & Doull's "Toxicology" Casa Editrice Ambrosiana
Contents
Principles of general toxicology: major areas of toxicology; toxic agents; exposure characteristics; classification of adverse effects; dose-response relationship; threshold effects; mechanisms of toxicity; toxicokinetics; risk assessment. Toxicology in drug development phases. Biotechnology-derived products: general aspects. Toxicology of biotechnology-derived medicinal products: monoclonal antibodies; cytokines and growth factors; blood derivatives; recombinant enzymes and hormones; recombinant vaccines; advanced therapy medicinal products; biosimilars. Biotechnology and sustainable development. Genetically modified organisms.
Course Language
Italian
More information
When required, the professor will commit to provide students with the most suitable material for exam preparation.
