Development of new drugs

Course goals

1. The student  can distinguish the first three phases of the development of a new drug (drug discovery, in vitro and in vivo development, describe the most important elements of the three phases and their function in the development path.
2. The student  can create a study design for preclinical research of a new drug
3. The student can critically evaluate the preclinical research file of a known drug that has been withdrawn from the market and make a proposal for additional preclinical research to re-introduce the drug on the market.
4. The student can interpret data from preclinical studies for a possible follow-up in clinical research.
5. The student can perform systematically a literature search for drug discovery and preclinical drug research: find literature/information, select, judge for relevance and analyse.
6. The student can define and judge ethical aspects of preclinical research.

 
The course Development of new drugs is recommended for the master Drug Innovation.

Content

“The volunteers fell like domino’s”
“My friend looks like ‘The Elefant Man”
March 2006: two subjects are in danger of life and four others are seriously ill after administration of an experimental drug.
These incidents illustrate the importance  of the preclinical phase for the development of new drugs, before they can be tested on human beings and brought on the market.
IN this course a group of students forms a pharmaceutical company that wants to bring a new drug on the market. This drug must be discovered and developed: the discovery phase. After this  it must be tested for its mode of action and whether it is safe to administer to human beings: the development phase. For both phases, pharmaceutical, biomedical and chemical knowledge is necessary. In these course students from different studies ( for instance Pharmacy, Biology, Biomedical Sciences and Chemistry) work together to develop a new and innovative drug.
By means of assignments, practical work, seminars and lectures the importance of the different phases illustrated. This knowledge and insight can be used by the development of the own new drug.
Finally, students write a research proposal for the new drug that has been withdrawn from the market but will be put in again. There is a price for the best proposal. Students participate in the selection for the winner.