This module will introduce the principles of formulation, manufacturing technology and product quality assurance of a range of commonly used pharmaceutical dosage forms. Students will learn a body of technical knowledge and acquire practical skills in the manufacture and product quality evaluation of solutions, emulsions, suspensions, ointments, gels, suppositories, sterile products, microcapsules, capsules, tablets, inhalation products, powders and controlled-release products.

This module is designed for those interested in advanced methods for pharmaceutical analysis, diagnosis, therapy, anatomical and functional studies, drug monitoring, drug discovery, research and development. The principles, pharmaceutical and biomedical applications of the following topics will be discussed: mass spectrometry (MS), bioanalytical method validation, biological sample preparations, magnetic resonance spectroscopy (MRS), magnetic resonance imaging (MRI) and other bioimaging methods etc.

At the end of the course, the students will be able to appreciate and understand the many different techniques and options available to them for analysis, diagnosis, therapy, anatomical and functional studies, drug monitoring, drug discovery, research & development. The students will also have the breadth of knowledge to formulate research questions in their own discipline and find appropriate solutions to solve them.

Students will learn the principles of QSAR studies based on multiple linear regression models. They will also be introduced to Comparative Molecular Field Analysis (CoMFA) and how to carry out and interpret CoMFA. In addition, application of multivariate data analysis to QSAR and how to carry out and interpret such analyses will also be covered in this module. Students will also learn how physicochemical properties may be altered for the optimization of the pharmacokinetics and pharmacodynamics properties of a drug molecule.

The main objective of this module is to understand the general principles and practices of process validation and its importance in providing a high degree of assurance that a process will consistently produce a pharmaceutical product meeting its predetermined specifications and quality attributes.

In this module, students will gain advanced knowledge in the area of tablet technology, with special emphasis on R&D work in pharmaceutical industries.

The objectives of this module are to review the basic principles underlying effective drug delivery in the human body, and to critically examine the approaches taken by pharmaceutical scientists to develop optimised drug delivery systems.

The main objective of this module is to teach the principles of formulating active pharmaceutical ingredients into pharmaceutical products. The students will acquire a body of technical knowledge in pharmaceutical ingredients, product development, stability and packaging.

Prerequisite: PR5217 Formulation Science

This is a practical module where students will spend time in the laboratory to acquire skills in:

• Synthesis, purification and characterization of active pharmaceutical ingredients (4 weeks)
• Formulation/ Drug delivery studies (4 weeks)
• Pharmaceutical technological/Process development (4 weeks)

The module will emphasize on proven quality management procedures such as “Six Sigma”, “Baldridge”, “Total Quality Management”, “Lean Management” and ‘Project Design and Management”. The module will also include various types of audits and inspections that occur in the pharmaceutical industry.

This module provides an introduction to the theory and application of recombinant DNA and cell culture technologies leading to the development and manufacture of biopharmaceutical products. Students will acquire the basic biological and engineering concepts of cell culture, bioreactors and fermentation processes, and an overview of the current Good Manufacturing Practices and quality control practices in the biopharmaceutical industry. The module will be conducted through lectures, tutorials and journal presentations. Students will be expected to do simple mathematical calculations and work in groups for the tutorial and journal presentations.

Prerequisite: PR3107 Pharmaceutical Biotechnology or by special permission

The aim of this module is to equip students with a better understanding of the molecular basis of modern drug discovery, with a special focus on drug target selection and validation. In this module, we will discuss intracellular signaling cascades, cell to cell signaling and pharmacological intervention in these processes. The use of animal models to select and validate molecular targets will also be covered. Students will gain an enhanced understanding of the drug discovery process which will complement their technical expertise in the field.

This module provides an introduction to the principles and practical applications of pharmacoepidemiology in the evaluation of the utilization, safety and effectiveness of therapeutic products (drugs, vaccines, biologics). Students completing this module should be able to grasp concepts and principles of pharmacoepidemiology in the context of drug evaluation and therapeutic decision-making, demonstrate knowledge, understanding and ability to critically evaluate the main study designs used in pharmacoepidemiology, as well as their strengths and weaknesses, and critically evaluate and interpret the results of pharmacoepidemiology studies in the published literature, including critical appraisal of the study design and methodology.

This module aims to introduce the rationale, principles and practical applications of pharmaceutical preformulation science in the development and manufacture of pharmaceutical products, highlight importance of material attributes on product quality, and provide an introduction to statistical methods relevant to preformulation/formulation. Students completing this module should be able to understand and describe the importance of pharmaceutical preformulation, describe and discuss the effects of material attributes on product quality, recognize and define critical material quality attributes associated with common pharmaceutical unit operations, understand and apply suitable techniques for characterization of materials in the development and manufacture of pharmaceutical products, and understand and apply suitable statistical methods for screening, optimization and assessment of excipients and product quality.

This module is designed to provide an introduction to the principles and practical applications of pharmacoeconomics and outcomes research. In addition, students are guided to perform critical evaluation of published literature in pharmacoeconomics and outcomes research.

Regulation of pharmaceuticals is controlled by standards, guidelines and legal frameworks. The interactions among these and the stakeholders – industry, regulatory authorities, healthcare professionals and patients – are required for effective governance for safe, quality and efficacious medicines and timely access for patients. This module provides the understanding of the contribution of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene. The concept of product life cycle will be also be explored among other contemporary regulatory approaches.

Ensuring quality of healthcare products is one of the key pillars in regulatory responsibilities, for industry, manufacturers and regulators. The contribution of Chemistry, Manufacturing and Controls (CMC) to a successful control of quality in pharmaceutical products spans from product development and manufacture, process validation to post-market variation changes, as well as an optimal quality management system. This module provides the foundation in understanding the regulatory science behind the development, manufacturing and control of pharmaceuticals, including the global guidances that shape the regulatory processes. Besides promoting good submissions and evaluation practices, the module aims to enhance regulatory convergence and cooperation on CMC regulation.