Learning objectives
To provide knowledge of the aims and methodologies adopted for the preclinical evaluation of the toxicological profile of drugs, with particular reference to biotechnology-derived pharmaceuticals
Prerequisites
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Course unit content
Safety assessment of biotechnology-derived pharmaceuticals:
Single-dose and repeated-dose toxicity studies
Reproductive and developmental, genotoxicity and carcinogenicity toxicity studies
Safety pharmacology
Examples of preclinical studies of biotechnology-derived pharmaceuticals.
Full programme
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Bibliography
Ballantyne B., Marrs T.C. General and applied toxicology. London, MacMillan (1993).
Klaassen C. Casarett and Doull’s toxicology. McGraw-Hill Italia (2008).
Teaching methods
Oral lesson
Assessment methods and criteria
oral exam
Other information
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