Pharmaceuticals - chemical analysis in projects D

The course includes theoretical and laboratory components, with a special emphasis on the latter. Module 1 Advanced analytical chromatography - theory and practice, 7.5 ECTS cr - Outline of analytical separation processes from a regulatory perspective - Advanced modern analytical separation theory - Different liquid chromatographic variants as reversed-phase chromatography, polar-phase chromatography, hydrophilic interaction chromatography, ion pair chromatography, and chiral separation of optical isomers - Modern chromatographic matrices such as pH stable phases, semi-porous phases, monoliths - Different trends in separation processes: Green modern chromatographic techniques, super critical fluid chromatography, miniaturisation and separation at high pressure - Outline of empirical and mechanical modelling of separation processes - Validation of chemical analysis methods - Sample preparation of analysis components/pharmaceuticals from different sampling matrices/preparation forms - Detection principles based on molecule spectroscopy and mass spectroscopy. Module 2 Chemical analysis in projects, 22.5 ECTS cr - classical unvariate statistical methods: descriptive statistics, hypothesis testing, sampling theory, variance analysis, and robust methods and their applications, - modern chemometric multivariate methods for analysis, classification, and calibration, factored trial planning and optimisation, - project methodology, including an inclusive approach, - introduction to chemical-technical production processes, - introduction to molecular interaction from a pharmaceutical perspective, - introduction to the metabolism of a number of drugs, - stability testing, stress testing, and common degradation products and production impurities for a number of different drugs, and - different industrial quality systems for conducting product analysis and bioanalysis. In the laboratory part of Module 1, students apply the theoretical components to a task that they get at the beginning of the course and report on it individually before the laboratory session. The task has a focus on the quality control of pharmaceuticals. Students are expected to plan and author the submitted laboratory compendium independently before the laboratory session. Students present the result of the completed laboratory work orally and in writing. In addition, students carry out and report on a risk assessment with consideration of quality requirements, time limits and the environmental requirements of an industrial pharmaceutical perspective. In Module 2, laboratory work is carried out in project form. The students work in groups to acquire knowledge and plan how to complete tasks. As the project progresses, they have to identify their need of further knowledge, and they themselves are in large part responsible for acquiring the knowledge/competence required. In groups, students apply the theoretical course content to the given problems, and present the results orally and in writing.