The main objective of this course is to provide the student with knowledge about the fundamental aspects of drug development and evaluation: mechanisms of action, pharmacological targets, pharmacokinetic processes and biopharmaceutical aspects, adverse effects, research methodologies in these areas and fharmacometrics.

Topic 01. Pharmacology. Definition. Past, present and future.

Topic 02. General concepts and mechanisms in the processes of absorption, distribution, metabolism and excretion of drugs. Pharmacokinetics.

Topic 03. General concepts and mechanisms involved in the action of drugs. Pharmacodynamics. General mechanisms of adverse reactions.

Topic 04. Phases of drug development. Role of pharmacokinetic/pharmacodynamic studies in understanding drug dose-response variability. Importance in the phases of drug development.

Topic 05. Role of the pharmaceutical industry in drug development.

Topic 06. Role of regulatory agencies (FDA and EMA) in drug evaluation.

Topic 07. Research and development methodologies regarding pharmacokinetic processes.

Topic 08. Research and development methodologies regarding pharmacodynamic processes.

Topic 09. Pharmacometrics. Role of modeling and simulation in drug development plans.

Topic 10. Current drugs and lines of development regarding cardiovascular system, endocrine system, central and peripheral nervous system, respiratory and digestive system, antibiotics, oncological drugs, immunomodulatory drugs.

• Final Assessment System