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 is aimed at having student gain a basic understanding of the origins, structures, impact and relevance of the myriad of laws in place to regulate the manufacture and distribution of drugs and devices. Emphasis is placed on the understanding of the purpose of the laws and their applicability to drug manufacturing as well as the acquisition of the ability to describe the elements in the laws/regulations that trigger the application.

This module is aimed at reviewing the drug discovery and drug development processes with an emphasis on the regulatory aspects of these activities. Animal pre-clinical research and human clinical research are discussed, along with the three phases of human clinical trials. The chemistry manufacturing and control (CMC) aspects of drug development are presented. The ICH documentation requirements and the application of manufacturing process analytical technologies will also be discussed. The course will conclude with a brief overview of patents and international regulatory issues.

This module will provide an overview of the FDA and ICH regulations on good manufacturing, good laboratory and good clinical practices. The meaning of these regulations, the globalization of the practices and the roles and responsibilities of the various professionals implementing these regulations are addressed.