The course will teach how to use and choose between assay for the whole chain of discovery, development and production of pharmaceuticals. Specific emphasis will be placed on the interaction between the different pharma steps and the assays associated with them, in other words how to always choose the fastest, most relevant, most easily implemented, interpreted and most cost-efficient assay. Basic assay principles, concepts and statistics for validation and development of assays and for evaluation of results will also be covered in detail as will the different types of equipment platforms and assay principles that are in use or will become available in the future. In addition some cases and examples of assays for personalised use for personalised medication as an example of assay-guided medication will be presented.
Læringsmål:
En studerende, der fuldt ud har opfyldt kursets mål, vil kunne:
• describe basic immunoassay principles and methods, quantitative as well as qualitative
• explain how to perform quantitative immunoassays and explain the different formats available
• describe principles and methods for high-throughput assays and their use in the drug discovery process
• describe how quantitative assays are validated and which criteria must be met to approve an assay for different applications
• understand the principles of cellular assays and other bioassays
• understand the principles of signal generation and signal detection in assays
• understand the use of microscopy for assay purposes, including the use of image treatment software
• describe the basic types of microarrays and their uses
• describe the principles and uses of the polymerase chain reaction (PCR) in different formats
• explain the principles of miniaturization and the application of assays for personal use
• explain how to treat assay data in a statistically sound way and how to design testing to obtain specific objectives
• apply the knowledge obtained in the course to select optimal assays for the different steps in the pharma process
Kursusindhold:
This course will provide the basic concepts for describing assay performance, will show how assays can be validated and how different types of assays can be used for different types of problems. In addition the principles and applications of different types of assays will be demonstrated, including immune-based assays, cellular assays, screening types of assays for compound library screening and quantitative molecular biology based assays (PCR type assays). Also signal generation methods including fluorescence and chemiluminescence will be explained. Finally the principles behind where to use which types of assays in the process of discovery, development and production of drugs will be shown.
