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Lecturer(s)
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Pejchal Vladimír, doc. Ing. Ph.D.
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Hejtmánková Ludmila, MVDr. Ph.D.
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Course content
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Basic field terminology. Phases of pharmaceutical product development. Chemical synthesis and analysis of pharmaceutical substances. Patents and their role in the pharmaceutical industry. Regulation of the pharmaceutical market. ICH Directive. Documentation of pharmaceutical products and registration procedures. Practical examples from the development of pharmaceutical substances. Students' practical exercises in the form of presentations of assigned projects. Pharmacochemistry as a tool for drug development.
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Learning activities and teaching methods
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unspecified
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Learning outcomes
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The aim of the course is to provide students with clear information on the development, registration and patent protection of medicines. Emphasis is placed on independent practice of the presented topic by students with a final presentation of the obtained data, their processing and interpretation. After completing the course, the student is introduced to the basic technical and administrative processes that accompany the development of medicines, especially active pharmaceutical substances. He is competent to find the necessary information about the product using a number of databases, propose methods of solving pharmaceutical projects, perform cost calculations and navigate basic documentation and patents related to the issue of pharmaceutical development. Completion of the course represents a significant advantage in the application of students in the pharmaceutical industry.
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Prerequisites
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The assumption for studying the subject is at least basic knowledge of organic and analytical chemistry, pharmacochemistry, chemical and pharmaceutical informatics.
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Assessment methods and criteria
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unspecified
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Recommended literature
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