This module provides the essential basis for several other topics that are presented in the course module “Clinical drug research. In the 'preclinical' part, special attention will be paid to all stages of drug discovery, ranging from initial chemical synthesis, the identification and validation of targets, in vitro and in vivo screening, primary and secondary pharmacology, toxicology, pharmacokinetics and pharmaceutical development, i.e. all the data that are needed for starting a phase I study in man.
· Overview of the most important pharmaceutical and biotechnological companies: reserach strategies, produt portfolio’s, etc..
· Biotechnological challenges and application in drug R&D
· General structure and operation of a farmaceutical and biotechnological company: Management, quality control, research and production, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
· Preclinical development: flowchart and process analysis
- Sources of new molecules via chemical, natural of biotechnological processes
- Pharmacological evalution: strategies and models, computer simulations, cellular and non-cellular screening, animal models, etc..
- Pharmacokinetics: absorption, distribution, metabolism and excretion (ADME).
- Toxicology: acute en chronic toxicity, mutagenesis, carcinogenesis, reproduction toxicity en ecotoxicity.
- Pharmaceutical development: dosing forms, stability, production requirements, e.a.