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Last update: Benešová Eva Ing. Ph.D. (16.09.2023)
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Last update: Benešová Eva Ing. Ph.D. (16.09.2023)
Students will be able to: Interpret results of pre-clinical and clinical studies Familiarize with new therapeutic trends |
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Last update: Benešová Eva Ing. Ph.D. (16.09.2023)
Z: Brody Z. Clinical Trials - Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Elsevier Amsterdam, 2012, ISBN: 978-0-12-391911-3 (Available online via National Library of Technology) Z: Svobodník A., Demlová R., Pecen L. at al. Klinické studie v praxi, ISBN 978-80-904731-8-8, Facta Medica, 2014, Brno (in Czech, available online via https://www.czecrin.cz) D: Středa L., Hána K. eHealth a telemedicína, Učebnice pro vysoké školy. Grada Publishing, a.s., 2016. ISBN 978-80-247-5764-3. |
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Last update: Benešová Eva Ing. Ph.D. (16.09.2023)
https://web.vscht.cz/~spiwokv/clinic/ Lectures in electronic form published at e-learning.vscht.cz Dictionary of Biomedicines and Fundamentals of Human Pathology available at e-learning.vscht.cz |
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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
Předmět bude zakončen písemnou a ústní zkouškou. Pro zápis na zkoušku nejsou žádné podmínky. |
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Last update: Benešová Eva Ing. Ph.D. (15.09.2023)
1. Pre-clinical studies 2. Design of clinical trials, randomization and blinding 3. Outcomes of clinical trials, superiority or equivalence testing 4. Clinical trial statistics and reporting (CONSORT) 5. Ethics of clinical studies, specificities of testing of new drugs, generics and biosimilars 6. Legislation A to Z - FDA, EMA, SÚKL 7. Personalized/precizion medicine 8. Biomarkers 9. Gene therapies - history, targets, strategies, vectors 10. Gene therapies - examples, ethics (help vs benefit vs damage) 11. Epigenetics - human genome and epigenome, regulations, currently marketed drugs and their mechanism of action 12. Nucleic acid based therapies 13. CRISPR-Cas 14. Invited talk |
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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
none |
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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
The course will be finished by a written and oral exam. There are no prerequisites for registration to the exam. |
Teaching methods | ||||
Activity | Credits | Hours | ||
Konzultace s vyučujícími | 0.5 | 14 | ||
Účast na přednáškách | 1 | 28 | ||
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi | 0.5 | 14 | ||
Příprava na zkoušku a její absolvování | 1 | 28 | ||
3 / 3 | 84 / 84 |
Coursework assessment | |
Form | Significance |
Regular attendance | 20 |
Examination test | 40 |
Oral examination | 40 |