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Education Postgraduate Studies PMQ Course Description
Education Postgraduate Studies PMQ Course Description
| Required Courses |
| PHAR 5511 |
| Regulation of Pharmaceutical Products |
| This course covers the framework of registration of drug products designed to meet international ethical and quality standards. Students will be expected to know the differences in regulatory requirements for patented and generic pharmaceuticals, for over-the-counter drugs and biological products, as well as ongoing efforts to harmonize drug regulation standards worldwide. |
| PHAR 5521 |
| Formulation and Process Development |
| This course covers the rational design, manufacture and testing of drug formulations, including tablets, capsules, liquids, suspensions, emulsions, aerosols, ointments, and advanced drug delivery systems. Other topics include sterile products, methods of sterilization, aseptic manufacture, and environmental monitoring. |
| PHAR 5531 |
| Quality Systems and Standards |
| This course covers the basic principles and concepts of quality control and assurance. The emphasis will be on current Good Manufacturing Practice and quality by design. |
| PHAR 5534 |
| Risk Management and Drug Safety |
| This course covers fundamental concepts of risk identification, detection, and management during the life cycle of pharmaceutical products, sources of drug safety risks, and mitigation of adverse drug events. |
| PHAR 5541 |
| Pharmaceutical Statistics |
| This course focuses on the application of statistical concepts and methodologies in drug product development, including formulation and process optimization, quality control, validation, clinical trials, and risk management. |
| PHAR 5614 |
| Pharmaceutical Engineering |
| This course covers the philosophy, project design and management, site selection, process flow design and documentation, process utility systems, design of laboratories, pilot plant, parenteral facility, automation of packaging systems, GMP and validation. |
| Elective Courses* (Students should take 6 units of elective courses) |
| PHAR 5130 |
| Overview of Drug Development |
| The course provides a comprehensive overview of the scientific, technological, clinical, financial, and regulatory aspects of drug development. It is open to students from all disciplines. |
| PHAR 5532 |
| Technical Writing in Drug Development and Regulation |
| This course covers three aspects of technical writing: (a) preparation and submission of documents to local and international drug regulatory agencies for registration of drug products; (b) technical documents required of compliance with quality assurance and labeling; and (c) documentation requirements for the qualification of instrumentation and equipment, including validation protocols and validation reports. |
| PHAR 5533 |
| Chemistry, Manufacturing and Controls |
| This course provides students with a firm foundation in the chemistry, manufacturing and control (CMC) process, from concept to commercialization of a new active pharmaceutical ingredient (API) and product. |
| PHAR 5611 |
| Physicochemical Properties of Drug Substances and Excipients |
| This course provides a step-by-step foundation for characterizing and setting specifications for active pharmaceutical ingredient (API), raw materials, intermediates, and excipients for conventional as well as advanced formulations. Impurities, stability, and analytical methodologies will also be discussed. |
| PHAR 5612 |
| Biopharmaceutical Characterization of Oral Dosage Forms |
| This course discusses the solubility and permeability of drug, focusing on the principles, methodology and optimization. Interplay of solubility and permeability in determining bioavailability as well as product development and regulatory action pathways are also discussed. The value of computing simulations will be examined. |
| PHAR 5613 |
| Bioavailability and Bioequivalence |
| The course covers the principles and applications of bioavailability in the development of brand and generic drug products. Formulation, genetic, and patient-specific factors influencing bioavailability are discussed. Design, conduct, and data interpretation of bioequivalence studies will also be discussed. |
| Project |
| PHAR 5569 |
| Graduation Project I |
| The project serves as a platform for students, either individually or in teams, to apply the knowledge and skills they have learned in course work to propose ways to strengthen the regulatory framework and/or to enhance compliance in their work place. This course will focus on developing a project plan, including defining the central question to be addressed, background, detailed experimental (investigational) plan, anticipated difficulties and alternate plans. Assessment will be based on a written proposal and oral presentation of the proposal. |
| PHAR 5579 |
| Graduation Project II |
| The continuation of the PHAR5569 Graduation Project I. This course will focus on implementing the proposed research plan, analyzing and interpreting the findings, and indicating the lessons learned. Assessment will be based on a written report and oral presentation of the report. |
| * Elective courses provided in different academic years might be different. |