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Lecturer(s)
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Pejchal Vladimír, doc. Ing. Ph.D.
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Course content
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Week 1 - Current trends in the pharmaceutical industry. Week 2 - Week 3 - Operations and equipment used in the manufacture of pharmaceutical products Week 4 - Good manufacturing practice - SVP (GMP). Week 5 - Isolation and packaging of pharmaceuticals - Clean rooms. Week 6 - Patent protection in the pharmaceutical industry. Week 7. - Week 8 - Laboratory drug development, Up scaling, technology development, semi-operational verification, Week 9 - Analytical methods, API morphology, excipients, Pharmacopoeia Week 10. - Week 11 - Laboratory development and production of selected pharmaceuticals. Week 12 - Documentation of results of laboratory drug development and manufacturing documentation. Week 13 - Drug Development Documentation, Registration Procedures.
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Learning activities and teaching methods
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unspecified, Skills training
- Contact teaching
- 52 hours per semester
- Contact teaching
- 52 hours per semester
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Learning outcomes
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The aim of the course is to introduce the audience to the development of pharmaceutical products technology, including starting materials and intermediates.
The student has basic knowledge about the development of pharmaceutical products technology, including the development of the technology in the GMP mode, after graduating.
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Prerequisites
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The student must have the basics of undergraduate physics, inorganic and organic chemistry, the basics of physical chemistry, all at the level of a successfully completed bachelor's degree.
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Assessment methods and criteria
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Oral examination
The student must have the basics of undergraduate physics, inorganic and organic chemistry, the basics of physical chemistry, all at the level of a successfully completed bachelor's degree.
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Recommended literature
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Hampl F., Rádl S., Paleček J. Farmakochemie. Praha, 2007.
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Johnson, D. The Art of Drug Synthesis. 2007.
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Kuchař M. Výzkum a vývoj léčiv. Praha, 2007.
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