Learning Objectives:

By the end of this course, you will understand:

• The size of the global pharmaceutical market and the key therapeutic areas being addressed by innovator companies
• The roles of different pharmaceutical professionals
• Typical costs and timelines associated with drug development
• How new drugs are developed against targets in the human body
• Reasons why drugs fail during development
• Factors affecting oral bioavailability
• How drugs are screened for toxicity
• The potential influence of polymorphism, salt form and isomerism on efficacy and safety
• How formulation can affect drug performance
• How the safety and efficacy of drug products are ensured during QC release testing
• The information obtained at each stage of clinical research
• The structure of regulatory submissions
• How post-approval changes to drug products are managed
• How the manufacture and distribution of marketed drug products are controlled