SMIMB1011U Discovery and Development of Medicines
Master's Program in Industrial Drug Development - compulsory
The topics taught are:
- Target evaluation and biopharmaceuticals
- Identification of lead structures
- Medicinal chemistry: Lead optimization and synthesis
- Non-clinical safety
- Animal biology and pharmacology
- Preformulation
- Pharmaceutical formulation
- Clinical trials
- Quality assurance
- Regulatory affairs
- Production
- Marketing
People involved in the development of medicines have diverse educational backgrounds. Often their basic academic educations have not at all touched upon discovery and development of medicines. This course aims to convey knowledge of drug discovery and development in general to the participants so they can communicate across the different fields of the process.
On completion of the course, participants will have a comprehensive overview of drug discovery and development and a sound grasp of the fundamentals of the major disciplines involved. Participants will be able to convey an understanding of the dynamics of drug discovery and development and communicate across research fields.
Upon completion of the course, students are expected to be able to:
Knowledge
- give a comprehensive overview of discovery and development of medicines
- identify correct professional terms in discovery and development of medicines
- list major steps and elements of the drug development process
- outline definitions of key concepts and the fundamentals of the major disciplines in drug discovery and development
- identify the important transition points that require the involvement of authorities
Skills
- appraise the integration of the various basic disciplines into the process of discovery and development of medicines
- analyze the sequence and flow of the various steps in the process of drug discovery and development
- plan a development process within the regulatory framework
Competencies
- liaise with all steps of drug discovery and development
- identify critical factors and bottlenecks that influence the drug development process
- promote and state milestones for the progress of the development of a medical product
- communicate professionally with the various specialist groups within the industrial area of development of medicines
The syllabus comprises collections of review papers, textbook
chapters and case stories and updated lecture slides, corresponding
to approximately 500 pages. All material will be distributed
electronically either placed on the course homepage or as a
USB.
Participants are expected to purchase: Drug Discovery and
Development. Technology in Transition, 3rd edition Humphrey P.
Rang, Churchill Livingstone, ISBN 9780702078040. Also available as
E-Book.
The Textbook of Pharmaceutical Medicine, 7th edition, 2013. John P.
Griffin (Editor), John Posner (Editor), Geoffrey R. Barker (Editor)
Blackwell BMJ Books serves as "nice to know" and it is
used in other MIND courses.
- Category
- Hours
- Lectures
- 40
- Preparation
- 78
- Theory exercises
- 20
- Exam
- 2
- Total
- 140
Registered students' register via the self-service on
KUnet.
New students apply via this link:
Discovery and Development of Medicines – University of
Copenhagen
- Credit
- 5 ECTS
- Type of assessment
- Oral examination under invigilation
- Type of assessment details
- The exam form is oral exam with physical presence.
The student picks 1 out of 12 topics (corresponding to the course modules) and then gets 15 minutes to prepare a 3-5 min. oral presentation. Then, in the 20 minute oral examination, the student presents the oral presentation, followed by questions on the topic and also other content of the course.
During the preparation, written aids are allowed, incl both printed and electronic documents and notes, but generative AI and internet are not allowed.
Handwritten notes may be made during the preparation, and only these notes may be brought to the examination. - Aid
- Written aids allowed
Both printed and electronic documents/notes are allowed, but generative AI and internet are not allowed.
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
- Exam period
- Re-exam
Same as usual.
Criteria for exam assesment
To achieve the grade of 12, the student must be able to:
Knowledge
- give a comprehensive overview of discovery and development of medicines
- identify correct professional terms in discovery and development of medicines
- list major steps and elements of the drug development process
- outline definitions of key concepts and the fundamentals of the major disciplines in drug discovery and development
- identify the important transition points that require the involvement of authorities
Skills
- The understanding of the integration of the various basic disciplines into the process of discovery and development of medicines
- The skill to analyze the sequence and flow of the various steps in the process of drug discovery and development
- The ability to plan a development process within the regulatory framework
Competencies
- liaise with all steps of drug discovery and development
- identify critical factors and bottlenecks that influence the drug development process
- promote and state milestones for the progress of the development of a medical product
- communicate professionally with the various specialist groups within the industrial area of development of medicines
Course information
- Language
- English
- Course code
- SMIMB1011U
- Credit
- 5 ECTS
- Level
- Part Time MasterFull Degree Master
- Placement
- Autumn And Spring
- Schedule
- See course webpage for specific dates.
- Course capacity
- 36 participants
Price
Fees are published on the course webpage .
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Drug Design and Pharmacology
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Anders Bach (11-6d7a70717e7f3a6e6d6f744c7f817a703a77813a7077)