Pharmaceuticals - chemical analysis in projects C

Instruction is in the form of theoretical and laboratory components, with a special focus on laboratory sessions. Part 1 covers the following: - survey of analytical separation processes from a regulatory perspective, - enhanced modern analytical separation theory, - various liquid chromatography techniques, - modern chromatography matrices, - modern trends in separation processes such as environmentally-friendly chromatography techniques, supercritical fluid chromatography, miniaturisation, and separation under high pressure, - survey of empirical and mechanistic modelling of separation processes - validation of chemical analysis methods, - sample preparation of analysis components/pharmaceuticals from different sample matrices/preparation formats, and - detection principles based on molecular spectroscopy and mass spectrometry. Part 2 covers the following: - 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 correlation 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 first part of the course, the theoretical components are applied to a given laboratory task which students are given when the course begins and which is presented before laboratory work is initiated. This task is focused on quality control of pharmaceuticals. The participants are expected to work independently to plan and write laboratory instructions which have to be approved before the laboratory session begins. Students then present the results of the laboratory work in writing. In the second part of the course, 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.