Kursplansdatabas för forskarutbildningskurser

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KURSPLANER FÖR FORSKARUTBILDNINGSKURSER

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Svensk benämning Immunogenicitet: Immunreaktioner mot biologiska läkemedel
Engelsk benämning Immunogenicity: Immune responses against biological drugs
Kursnummer 3067
Antal högskolepoäng 1.5
Kursansvarig institution Institutionen för klinisk neurovetenskap
Särskild behörighet
Betygsskala Godkänd/Icke godkänd
Fastställd av The Board of Doctoral Education
Datum för fastställande 2019-01-14
Kursens syfte Understanding of central terms and definitions in the field of immunogenicity, used in research and in clinical applications. To become familiar with the identified molecular and cellular immunological processes that trigger and increase the risk for developing anti-drug antibodies (ADA). Understanding of how immunogenicity needs to be taken into consideration all the way from choosing your biological target of treatment, to drug development, approval, clinical routine and individualized therapy and health care practice.
Kursens lärandemål At the end of the course the student should be able to:
- Understand what determines the immunogenicity of drugs and why they differ in this respect.
- Give examples of different methods of how to measure drug level and ADA.
- Understand the algorithms needed in clinical practice and what consequences ADA might have for treatment decision, safety and efficacy.
- Integrate this knowledge in your own research project or a disease and treatment of choice.
Kursens innehåll The course will give you an orientation of the clinical research fields where treatment with biopharmaceuticals are important and how the immune system can react against different biopharmaceuticals. It will include the diseases MS, RA, IBD, and SLE and biopharmaceuticals like IFNbeta, natalizumab, rituximab, TNF-blockers as well as the biosimilars for these. A range of immunoassay methodologies that can be used to measure drug levels and ADA will be presented and the clinical relevance of the test results discussed. The course will also give insights on the type of research being done to identify risk factors for ADA, and optimisation of drug design, production and administration to minimize the risk. Ways to improve treatment regiments adopted to results of drug level and ADA, as well how to monitor and store data in clinical routine will be discussed.
Arbetsformer Lectures, individual essays, peer-review and oral presentation.
Obligatoriska moment Lectures, essay, peer-review and oral presentation. Absence from lectures can be compensated for by writing an additional essay on the subject missed.
Examination Essay, peer-review and oral presentation.
Kurslitteratur och övriga läromedel Articles selected by the teachers and by own literature search in PubMed or other data bases.
Kursansvarig Anna Fogdell-Hahn
Institutionen för klinisk neurovetenskap

0705-449060
Anna.Fogdell-Hahn@ki.se

CMM


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