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Within the course "Development of a medicinal product", students will get acquainted with the whole process of drug form development - from characterization and selection of the active substance, formulation processes, clinical testing to the launch of the medicinal product. Individual lectures will be designed from the explanation of the theory to demonstrations on real examples from pharmaceutical practice. It will be shown how to apply knowledge of analytical, organic and physical chemistry together with the basics of chemical engineering and biochemistry in drug development. Individual lectures will be presented by experts from the pharmaceutical company Zentiva
After completing the course, the student will be able to: - Explain the physicochemical properties of active pharmaceutical ingredients. - Describe the processes of absorption, distribution, metabolism, elimination, and toxicity. - Determine BCS classification. - Clarify the reasons for patenting in the pharmaceutical industry. - Identify the relationships between different solid forms of active ingredients. - Evaluate the application of analytical techniques in reverse engineering. - Describe various formulation processes in the pharmaceutical industry. - Describe classical analysis methods and separation techniques. - Propose procedures for optimizing formulation processes when scaling up to industrial scale. - Evaluate and prepare essential parameters for clinical testing. - Explain the strategies, rules, and procedures for the registration of a medicinal product. Last update: Kozlík Petr, doc. RNDr., Ph.D. (29.01.2024)
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Zkouška bude písemná s možností ústního prezkoušení. Zkouší se to, co bylo odpřednášeno. Test je nutné složit alespoň na 60%. Last update: Kozlík Petr, doc. RNDr., Ph.D. (29.01.2024)
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1. Introduction to the training program and its specifics, general description and new trends in the pharmaceutical industry Last update: Kozlík Petr, doc. RNDr., Ph.D. (28.05.2020)
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