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The student has one of the following Bachelor degrees:
- Biomedical sciences
- Biochemistry
- Farmacy
- Veterinary sciences
- Medicine
 
Students from other disciplines or with a relevant professional knowledge or training prior may register using the training module PAVO.

- 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"

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.

Lecture material : Reproduction of the powerpoint slides used during the lectures 
 
Book: Drug discovery and Development, Rang HP (Ed.), Churchill Livingstone, Elsevier, 2006.

Supportive material : Blackboard: slides in colour (download pdf), practicum notes, enyclopaedic reference, useful electronic links, etc..