To give the students an understanding of the polytechnical nature of engineering and drug discovery in the pharmaceutical industry involving many disciplines such as: Industrial Biotechnology, Chemical Engineering, Biochemistry, Medicinal Chemistry, Pharmacology, Toxicology, Preclinical and Clinical Investigations, Manufacturing, Regulatory Affairs, Good Industrial Practices, (GXP), Patent issues, etc.
Læringsmål:
En studerende, der fuldt ud har opfyldt kursets mål, vil kunne:
• Explain how in-silico approaches can be used together with bioassays for the discovery, design and development of novel small organic lead compounds.
• Demonstrate general knowledge of assay technologies and their roles and importance in drug discovery and development of e.g. antibiotics
• Explain the basic principles behind different types of drug-receptor interactions (small molecule-protein and protein-protein interactions).
• Master calculations of pharmacokinetic and pharmacodynamic properties of drug candidates taking different types of formulations into account.
• Explain the basic mechanisms of drug metabolism and how it relates to toxicology
• Understand the procedures involved in the different phases of preclinical and clinical trials
• Give a broad account of the up- and down-stream processes involved in biotechnological based drug manufacturing
• Give a broad account of the analytical methodologies necessary for control of the purity of the final drug product.
• Demonstrate a general knowledge of patent issues and the role of different regulatory authorities at various stages during the drug discovery process
• Give a basic account of GXP in drug development.
• Demonstrate knowledge of how drug production is planned and executed for both small molecules and biopharmaceuticals
• Explain the interplay between all the above mentioned individual disciplines.
Kursusindhold:
The course gives an introduction and overview of the different elements in pharmaceutical drug discovery and development. Exercises will be given supporting the theoretical content. Major case stories are presented in collaboration with Danish pharmaceutical companies that are visited on
