CHEM 392 is a core course for students enrolled in BSc. Specialisation in Medicinal Chemistry. This course will prepare students for advanced Medicinal and Pharmaceutical courses at the post-graduate level and for jobs in the pharmaceutical industry. This course covers a broad range of issues that are important in the design, development, and marketing of new pharmaceuticals. Students are introduced to the Ministry of Health's policies on drug regulatory framework and how Pharmac decides on drug subsidies in New Zealand and the rationale for it. There is then a module of 5-6 lectures given by patent attorneys on ways of protecting intellectual property and patent law in the pharmaceutical industry as well as litigation. We then cover new ways in which drugs are discovered and have a lecture on biological drugs-a fast growing and very lucrative area.
Good Manufacturing Practices (GMP) in the pharmaceutical industry which includes GMP policies is covered, technical aspects applied to process development delivered by Douglas Pharmaceuticals which culminates in a site visit to a local pharmaceutical company
Time is give and scale-up of active pharmaceutical ingredients and the ways to approach this safely. The course has 2-3 lectures dedicated to the different aspects of clinical trials including design of clinical trials, drug formulation and ethical considerations. Several examples of successful -FDA approved drugs and their development carried out in the University's research labs are given as 4-5 hours of lectures by scientists in the field. Commercialisation models for intellectual property developed in the university setting are also covered in this course.