Drug discovery and development: classical approaches and new strategies. Introduction to the pharmacokinetic principles (drug absorption, distribution, metabolism and excretion) and to the pharmacodynamic concepts (dose-response curve, agonism and antagonism). Early efficacy, safety and pharmacokinetic assessment of drug candidates: in silico and in vitro models for pharmacological profiling of new chemical entities. Cell- and tissue-based models in pharmacological evaluation. Animal models in drug research: guidelines for the care and use of laboratory animals. Disease animal models to the pharmacodynamic evaluation of new drug candidates: cardiovascular, antidiabetic, anti-obesity, psychotropic and neurotropic, learning and memory, anti-inflammatory-analgesic-antipyretic, and anti-cancer activity. Non-clinical toxicology assays: single-dose and repeated-dose toxicity, genotoxicity, carcinogenicity, and reproductive toxicity.