Learning objectives
<div align="justify">To provide knowledge of the aims and methodologies adopted for preclinical safety evaluation of drugs, with particular reference to biotechnology-derived pharmaceuticals</div>
Prerequisites
<div align="justify">Basi molecolari dell'azione dei farmaci</div>
Course unit content
<p>Safety assessment of biotechnology-derived pharmaceuticals:<br />
</p>
<ol>
<li>Single-dose and repeated-dose toxicity studies</li>
<li>Reproductive and developmental, genotoxicity and carcinogenicity toxicity studies</li>
<li>Safety pharmacology</li>
</ol>
<p>Examples of preclinical studies of biotechnology-derived pharmaceuticals.<br />
</p>
Full programme
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Bibliography
<div align="justify">Ballantyne B., Marrs T.C. General and applied toxicology. London, MacMillan (1993).<br />
Klaassen C. Casarett and Doull’s toxicology. McGraw-Hill Italia (2001).<br />
</div>
Teaching methods
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Assessment methods and criteria
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Other information
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