|Course Code :||2031FBDBMW|
|Study domain:||Biomedical Sciences|
|Semester:||Semester: 1st semester|
|Study load (hours):||168|
|Contract restrictions: ||No contract restriction|
|Language of instruction :||English|
|Exam period:||exam in the 1st semester|
At the start of this course the student should have acquired the following competences:
An active knowlegde of :A passive knowledge of :Specific prerequisites for this course:
The student has one of the following Bachelor degrees:
- Biomedical sciences
- Veterinary sciences
Students from other disciplines or with a relevant professional knowledge or training prior may register using the training module PAVO.
2. Learning outcomes
- The student has a theoretical understanding of all phases of preclinical drug development by pharmaceutical and biotechnology companies.
- The student is able to judge preclinical data in a registration dossier accurately as well as to recognize the relevance of these data for clinical research and development.
- The student can analyse a scientific insert of a drug in sufficient technical detail and is able to develop a study plan for supporting experiments and studies and fit these in a standard drug R & D flow-chart and time schedule.
This module provides basic knowledge needed for the modules "Clinical biomedical research techniques" and- "Clinical research CRA- CSA based training module"
3. Course contents
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 portfoloi’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.
4. Teaching method
Class contact teaching: LecturesSeminarsTutorials
5. Assessment method and criteria
Examination: Oral with written preparationClosed bookOpen-question
Continuous assessment: Case studiesParticipation in classroom activities
6. Study material
: Reproduction of the powerpoint slides used during the lectures
Book: Drug discovery and Development, Rang HP (Ed.), Churchill Livingstone, Elsevier, 2006.
The following study material can be studied on a voluntary basis:
Supportive material : Blackboard: slides in colour (download pdf), practicum notes, enyclopaedic reference, useful electronic links, etc..
7. Contact information
(+)last update: 26/01/2013 15:51 louis.maes