Technology and Pharmaceutical Legislation and Toxicology Ii

The aim of the course is to introduce the students to the main classes of xenobiotics (natural and synthetic molecules) exerting toxic effects on humans. Exposure conditions are examined, the toxic effects are described, and the molecular mechanisms explaining the toxicity of the different molecules are analyzed. Experimental and epidemiological data defining the risk assessment are critically analysed. The course also aims at introducing the principles underlying the production of the main conventional and modified-release pharmaceutical forms for acquiring the knowledge necessary to understand the relationships between manufacturing technologies of the different pharmaceutical forms and the risks for operators and the environment. The main specific criticalities of the technologies for the industrial preparation of pharmaceutical forms and the various methods of reducing the risks adopted will be illustrated in detail.

At the end of the course the student must demonstrate to possess an adequate knowledge of the toxic effects of natural and synthetic molecules and of the mechanisms explaining their toxicity. The student is also expected to be able to critically analyse toxicological issues, based on the available data: experimental, occupational and epidemiological. Student must also hold the fundamental pharmaceutical technologies for the purpose of mitigating the risks to the health of operators and to the environment associated with the development and production of medicinal products in the industrial field.