Master Students will acquire general and specific knowledge and understanding in Reglatory Science concerning studies needed to build preclinical development program of any medicine, consisting of a small molecule, biotechnology or gene or cell based product. They will learn on the content and basis of the European and international guidelines behind the different studies and will be able to interpret these guidelines and to apply them in the different situations. Students will acquire the competency for designing the preclinical development programs of different types of medicines to support their clinical research and marketing authorization applications in Europe and in the US, and will be able to discriminate the needs also in terms of the different target patient populations, eg women of chilbearing potential, post menopausal, children, elderly, etc.
Preclinical development program of new pharmaceuticals.The International Conference of Harmonization (ICH) guideline ICHM4.Single and repeated dose toxicity studies; duration, design and guideline (ICH S3).Safety pharmacology, core program (ICH S7A) and studies assessing the antiarrytmic potential (ICHS7B).Genotoxicity Studies-ICH S2.
Reproduction toxicity studies:ICH S5 R2;”pregnancy labelling: the EU guidance”.Carcinogenicity studies: ICH S1.Special studies for phototoxcity, local tolerance and immunogenicity.Principles for estimating the First in Human(FIH)dose of human pharmaceuticals;preclinical studies to support FIH studies.Preclinical studies supporting clinical trials/marketing authorization of new pharmaceuticals, (ICH M3 R1).Preclinical development of biotechnology medicinal products:guideline ICH S6 R1.development of pediatric drugs, the european guidelines on the use of juvenile animal studies; the ICH ongoing discussions.Preclinical development of oncology drugs (ICH S9).