PRECLINICAL DRUG STUDIES unit A
Learning outcomes of the course unit
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
Course contents summary
Safety assessment of biotechnology-derived pharmaceuticals:
Single-dose and repeated-dose toxicity studies
Reproductive and developmental, genotoxicity and carcinogenicity toxicity studies
Examples of preclinical studies of biotechnology-derived pharmaceuticals.
Ballantyne B., Marrs T.C. General and applied toxicology. London, MacMillan (1993).
Klaassen C. Casarett and Doull’s toxicology. McGraw-Hill Italia (2008).
Assessment methods and criteria