Syllabus database for doctoral courses
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Syllabus database for doctoral courses
SYLLABI FOR DOCTORAL COURSES
| Swedish title | Säkerhetsbedömning i läkemedelsutveckling |
|---|---|
| English title | Safety assessment in Drug Discovery and Development |
| Course number | 2821 |
| Credits | 1.5 |
| Responsible KI department | Institutet för miljömedicin |
| Specific entry requirements | |
| Grading | Passed /Not passed |
| Established by | The Board of Doctoral Education |
| Established | 2014-09-09 |
| Purpose of the course | |
| Intended learning outcomes | After the course the student should be able to: discuss the role of safety assessment during the drug discovery and development process; evaluate how animal and human data can affect the decision to pursue or discontinue a drug project; identify important parameters when going from preclinical to clinical studies; and critically discuss how predictive methods could affect the drug discovery and development process. |
| Contents of the course | The course identifies the different steps of the entire process of drug discovery and development, and the critical role played by safety assessment in a drug project moving through that process. The students will discuss and practice the assessments needed during the discovery and development phases, as well as the post-marketing phase. The importance of a safety assessment during target identification is highlighted, and special emphasis is put on how to include and evaluate toxicologically relevant in silico, in vitro and in vivo methods into a drug project during the discovery phase. The regulatory requirements, covering both pre-clinical and clinical studies in the development phase, are explored, with the aim to enable the students to put animal and human data into a regulatory context. Translational safety assessment, which bridges the gap between animal and human studies, is a special focus area. New relevant methods (such as adverse outcome pathways and non-animal methods), enabling a predictive approach to the process, are introduced. The occurrence and importance of pharmaceuticals in the environment is discussed. |
| Teaching and learning activities | The course includes lectures, discussions, and group assignments. |
| Compulsory elements | Participation in practical exercises and group assignments are compulsory. Absence can be compensated with an individual assignment. |
| Examination | Examination is in the form of presentation and discussion of a group assignment. Every student is individually assessed. If necessary this is complemented by oral questioning (for individual examination). |
| Literature and other teaching material | Course responsible |
Annika Hanberg Institutet för miljömedicin 08-52487526 Annika.Hanberg@ki.se |
| Contact person |
Johanna Bergman Institutet för miljömedicin johanna.bergman@ki.se Nobels väg 13 17177 Stockholm |
