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. 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 drugs and metabolites in biological fluids. Examples of drug development. Case studies of selected drugs from design to release.