Method of examination: Course work and written or oral examination
Credit points: 6

Module Head: Dr. Klaus Olejniczak

No		Topics
1		Regulatory background Council regulations/German Drug Law (AMG) Preclinical guidelines/ICH process GLP General principles of toxicity studies Animal welfare In vitro studies The preclinical scientific advise procedure
2		Pharmacologictoxicological documentation Common Technical Document (CTD-S) Nonclincal overview / summaries Bibliographic documentation
3		Pharmacology Objectives Pharmacodynamic effects relating to the proposed indications Safety pharmacology Assessment of the potential for QT-interval prolongation Drug interaction
4a		Pharmacokinetics/toxicokinetics/metabolism Objectives Pharmacokinetics after a single dose Pharmacokinetics after repeated administration Distribution in normal and pregnant animals e.g. autoradiography, biotransformation Repeated-dose tissue distribution studies The assessment of systemic exposure in toxicity studies/toxicokinetics Pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products In vivo drug metabolism/drug interaction studies
4b		Juvenile toxicity testing
5a		Single dose/repeated-dose toxicity Objectives Species selection Route of administration Duration, dose frequency Number of animals and groups Data evaluation and presentation The assessment of systemic exposure in toxicity studies/toxicokinetics
5b		Local tolerance / phototoxicity
5c		Inhalation toxicity
6		Reproductive toxicology Objectives Fertility and early embryonic development Embryo-fetal development Prenatal and postnatal development, including maternal function
7		Genotoxicity Background, reasoning for testing for interactions with genetic material, relationship to animal carcinogenicity testing Regulatory experience with submissions Different modes of action, importance of metabolism, threshold mechanisms in genotoxicity Regulatory models Animal models for risk assessment
8		Specialities (1) High Throughput Screening (HTS) models In silico models for toxicity prediction Toxicogenomics
9		Carcinogenicity Need for carcinogenicity studies of pharmaceuticals Testing for carcinogenicity of pharmaceuticals Dose Selection for carcinogenicity studies of pharmaceuticals
10		Specialities (2) Preclinical testing strategies Timing of preclinical studies Biotechnology-derived products
11		Specialities (3) Anticancer drug development Impurities Environmental toxicity
12		The preclinical section of the SPC