SLVKB0391U Drug Discovery and Development

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - compulsory, MSc in Medicinal Chemistry - elective
Content
In order to give students insight into and an overview of the drug discovery and development process in the pharmaceutical industry, lectures and class lessons are given on the following topics:
  • Target identification, evaluation and identification lead structures
  • Medicinal chemistry: Lead optimisation and synthesis
  • Non-clinical safety assessment
  • Pharmacology
  • Pre-formulation
  • Pharmaceutical formulation
  • Clinical trials
  • Regulatory affairs
  • Production
  • Marketing
Lectures give students an overview of drug discovery and development in an industrial perspective.
Class lessons allow students to discuss topics of special interest or problem areas in drug development with scientists from PHARMA or the pharmaceutical industry, as well as other students. Since students will have earned their bachelor degrees in various fields, the class lessons will also give them the opportunity to train their ability to communicate in an interdisciplinary environment. Students work on a project in conjunction with the lectures and class lessons on the topics listed.
In groups of three or four, students carry out a project under the guidance of a Pharma School-based scientist. The objective is for the students to deal with the elements of drug discovery and development of a registered drug. The students carry out literature searches and write a number of synopses on topics related to the drug discovery and development of the drug in question.
Learning Outcome
To introduce students to the various phases involved in drug discovery and development, as well as to give them an overview and a solid understanding of the dynamics and interdisciplinary nature of the development process. The course is built around a project that the students work on for the entire duration of the course. Information needed for the project is found in the course materials. The specific project goals are for students to:
  1. Gain an overview of drug discovery and development in an industrial perspective,
  2. Acquire knowledge of the academic disciplines involved in drug discovery,
  3. Gain an understanding of the positioning and importance of their own academic profile relative to industrial drug development,
  4. Learn to detect key issues associated with each of the phases (from discovery to post-marketing) in a drug development process.

At the end of the course, students should have a solid overview of the academic disciplines, interdisciplinary nature and dynamics of drug development. More specifically, the student should be able to demonstrate:

  1. Understanding of the basic academic disciplines involved in drug discovery and development
  2. Understanding and ability to use the basic technical terms used in drug discovery and development
  3. The ability to identify critical parameters in industrial drug development
  4. Understanding of his or her own professional role in the drug development process seen in relation to his or her own expertise and academic profile.
  5. The ability to define key issues associated with a drug development process.
Literature
Drug discovery and development 2nd Edition technology in transition, Churchill Livingstone Elsevier. Ed.: R.G. Hill and H.P. Rang. ISBN 9780702042997

Alternatively: Drug discovery and development technology in transition, Churchill Livingstone Elsevier. Ed.: H.P. Rang. ISBN-13: 978-0-443-06420-3, ISBN-10: 0-443-06420-2.
Course teaching is based on the assumption that students have completed a bachelor’s degree in the natural, health or technical sciences, or a corresponding qualification at bachelor’s level.
•11 lectures (45-minutes)
•11 class lessons (45-minutes)
•1 class lesson as an introduction to the course and project work (45-minutes).
Åbent for gæstestuderende. Kurset er IKKE åbent for studerende, der har bestået kurset "Clinical Drug Development".
  • Category
  • Hours
  • Exam
  • 40
  • Guidance
  • 76
  • Lectures
  • 12
  • Preparation
  • 24
  • Preparation
  • 36
  • Theory exercises
  • 18
  • Total
  • 206
Credit
7,5 ECTS
Type of assessment
Oral defence, 15 minutes
The examination lasts 15 minutes, plus 15 minutes of preparation time. The examination is based on the prepared synopses.
Exam registration requirements
To be eligible for the examination, the student must have submitted synopses and participated in the oral presentation of the synopses.
Aid
Only certain aids allowed
  • Permitted aids for exam preparation: All written materials and personal computer
  • Permitted exam aids: Own notes from exam preparation
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment
12 - Excellent performance
A profound understanding of the basic academic disciplines involved in drug discovery and development. The student demonstrates a comprehensive understanding of basic technical terms used in drug discovery and development and participates actively in lectures, class lessons and project work. The student demonstrates:
  • the ability to identify critical parameters in industrial drug development
  • the ability to define key issues associated with a drug development process
7 - Good performance
A coherent understanding of the basic academic disciplines involved in drug discovery and development. The student demonstrates a coherent understanding of basic technical terms used in drug discovery and development participates actively in lectures, class lessons and project work. The student demonstrates, with few minor weaknesses:
  • the ability to identify critical parameters in industrial drug development
  • the ability to define key issues associated with a drug development process
02 - Acceptable performance
A limited understanding of the basic academic disciplines involved in drug discovery and development, with a number of weaknesses. The student demonstrates, with a number of weaknesses, a limited understanding of basic technical terms used in drug discovery and development participates actively in lectures, class lessons and project work. The student demonstrates, with a number of weaknesses:
  • the ability to identify critical parameters in industrial drug development
  • the ability to define key issues associated with a drug development process.