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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
Students will be able to: Interpret results of pre-clinical and clinical studies Familiarize with new therapeutic trends (gene and cell therapies, regenerative and transplantation medicine) |
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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (10.08.2022)
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) |
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Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
https://web.vscht.cz/~spiwokv/clinic/ |
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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: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)
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. Gene therapies - history, targets, strategies, vectors 8. Gene therapies - examples, ethics (help vs benefit vs damage) 9. Epigenetics - human genome and epigenome, regulations 10. Epigenetics - current marketed drugs, their mechanism and newly developed compounds 11. Regenerative medicine 12. Cell transplantation and xenotransplantion 13. Invited talk - Practical aspects in clinical trials of new drugs 14. Invited talk - Clinical trials in the Czech Republic and the world
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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 |