90827 - Safety Pharmacology and Toxicology of Biopharmaceuticals

Learning outcomes

At the end of the course, the student has knowledge of: - the phases of discovery and development of a new biotechnological drug, with particular attention to safety aspects; - the molecular and cellular mechanisms of toxicity of biotechnological drugs; - the systemic toxicity of biotechnological drugs in organs and systems.

Course contents

New biopharmaceutical drugs are characterized by discovery and development phases with peculiar aspects concerning the evaluation of both the efficacy and the safety profiles. The different classes of biopharmaceuticals present specific toxicity mechanisms at the cellular and molecular level, as well as at the systemic level in organs and apparatus. Therefore, specific evaluations of safety pharmacology and toxicology are required to characterize new biopharmaceutical drugs.

Objectives:

The objective of the course is to provide the student with an overview of the discovery and development phases of a new biotechnological drug, with particular focus on the safety aspects, the cellular and molecular mechanisms of toxicity of biotechnological drugs, and the systemic toxicity of biotechnological drugs in organs and apparatus.

Course contents

• 1-Discovery and development of a new biotechnological drug: meaning, scope and description of the efficacy and safety profile related to the preclinical and clinical phases. Toxicological studies of biotechnological drugs.
  
• 2-General toxicology: types of adverse effects; factors conditioning the toxicological effects of biotechnological drugs; adsorbtion, distribution, metabolism and elimination of a toxic compound. toxicogenetics, genetic polymorphisms affecting the metabolism, the transporters, the therapeutic targets.
• 3-Mechanisms of toxicity: mechanisms of cellular death (necrosis, apoptosis, autophagy, pyroptosis); genetic toxicity; cancerogenesis.
• 4-Systemic toxicology: nature, site and mechanisms of toxicity of biotechnological drugs at the level of the principal organs and systems.

Teaching methods

Frontal Lessons

Assessment methods

The final examination will be an oral evaluation regarding the course contents.

Office hours

See the website of Roberto Tonelli