3 ECTS credits
80 h study time
Offer 1 with catalog number 4012654ENR for all students in the 1st and 2nd semester at a (E) Master - advanced level.
The first crucial step in the stage of Drug Discovery is the determination of the drug target in order to cure, prevent or modify a certain disease state. Mostly it consists of the identification of a functional protein involved in the disease or that can be used as a biomarker of the disease. Next to the rational developed mechanism-based drugs, more drugs will arise from DNA microchips, genomics, proteomics, glycomics and metabonomics research. Then a lead compound that can interact with the chosen drug target should be developed, here we talk about the stage of Drug Design. Alternatively, a natural occurring molecule can also be used as a lead compound. Then several years of pharmacological studies with chemically related compounds will follow in order to investigate the mechanisms of action, effects, adverse effects, selectivity, stability, etc. We will focus on several in vitro, in vivo and in silico models and experimental set-ups that are used in drug targeting and pharmacological profiling studies of the molecules being tested. One may not overlook the importance of behavioural studies with animals.
A second stage, although overlapping with pharmacological profiling studies, is Non-Clinical Development. In this stage in vitro, in vivo and in silico experiments are performed as well. The major aim of Non-Clinical Development is to fulfil all criteria before the test compound can be administered to human beings. The molecule will be tested extensively for undesired pharmacological effects. Toxicological tests in at least two animal species should show absence of genotoxicity and lack of organ damage within short-term use of the drug. Moreover, a pharmacotherapeutic range should be determined in animals. In this stage of drug development, many pharmacokinetic studies are set up in order to get insight into the ADME properties of the molecule. On the other hand, the chemists and pharmaceutical technologists are aiming to produce large quantities of the pure compound and to develop a pharmaceutical preparation applicable for clinical studies.
Non-Clinical Development is still ongoing (e.g. long-term toxicity studies) while Clinical Development departs. Phase I Clinical Development trials are performed on a small group of healthy volunteers to check for safety and tolerability of the molecule as well as to confirm the pharmacodynamic effect in human beings. Pharmacokinetic properties in humans are also determined. Phase II studies are performed on groups of patients and are designed to test for efficacy in the clinical situation, as well as extending the phase I studies to include patients as well as healthy volunteers. When new drug targets are being studies, it is not until these phase II trials are completed that the team finds out whether or not the initial hypothesis was correct: lack of expected efficacy is a common reason for failure. Phase III are the definite double-blind randomised trials commonly performed as multicentre trials on larger groups of patients, aimed at comparing the new drug with commonly used alternatives. Phase IV studies comprise the obligatory postmarketing surveillance designed to detect any rare or long-term adverse effects resulting from the use of the drug in a clinical setting in many thousands of patients. Such events may necessitate limiting the use of the drug to particular patient groups or even withdrawal of the drug from the market.
When discussing both pharmacological profiling as well as toxicological studies, several examples will be given that are situated in the field of expertise of the lecturers, such as liver-based in vitro models for pharmacotoxicological research, in vivo neuropharmacology, neuropsychopharmacology, renal household and pharmaco-kinetic studies. Topics such as extrapolation from animals to humans and patenting of research data will also receive special attention.
Powerpoint presentations used during the lectures are made available on the e-learning platform
To acquire knowledge on the characteristic stages that a drug in development needs to pass before it can reach the market. To get an overview of research methods, techniques and strategies possibly involved,. By the end of the course, students apply their new knowledge to discuss some research manuscripts.
The final grade is composed based on the following categories:
Written Exam determines 100% of the final mark.
Within the Written Exam category, the following assignments need to be completed:
Written exam, mostly open questions, some multiple choice questions are possible.
The exam consists of 3 separate parts. For each part, students get a score out of 10 from the respective lecturer. The total score is calculated as the artihmetic mean of the scores of the 3 separate parts.
This offer is part of the following study plans:
Master of Biology: Education (only offered in Dutch)
Master of Biology: Molecular and Cellular Life sciences
Master of Teaching in Science and Technology: biologie (120 ECTS, Etterbeek) (only offered in Dutch)