Pharmaceutical Drug Development

• 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.
• Give a broad account of protein stability and protein aggregation.

The course gives an introduction and overview of the different elements in biopharmaceutical drug discovery and development. Exercises will be given to support the theoretical content. Major case stories are presented in collaboration with Danish pharmaceutical companies.

Basic knowledge about organic chemistry and biochemistry

Lectures, exercises and group work.

Relation to many courses at DTU.