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School of Chemical Sciences

Course details: CHEM392 Issues in Drug Design and Development

Description: Intellectual property and patent law in the pharmaceutical industry. An overview of the legal and regulatory framework for drug design and development. Clinical trials: formulation of a drug; phase I, phase II and phase III protocols and ethical considerations. An introduction to the principles involved in the Codes of Good Manufacturing Practice and Good Laboratory Practice (quality control and quality assurance procedures) as applied to the manufacture of drug products and the quantification of drug and metabolites in biological fluids. Occupational health and safety issues. Examples of drug development. Case studies of selected drugs from design to release.

Semester: Second Semester
Coordinator: Dr Vijayalekshmi Sarojini
Phone: + 64 9 3737599 ext 83387
Room: 529-307
Laboratory: There is no formal laboratory course, however visits to pharmaceutical companies will be arranged
Assessment: Final Examination 50%; assignments and site visits 50%