Programme Structure 

Candidates admitted into the Master degree program must read and pass a total of 10 modules (40 MC), comprising 6 essential modules and 4 elective modules: 

(a)  6 Essential Modules (24 MC) 

(i)   PR5301 Food and Drug Laws

(ii)   PR5302 Regulation of Drug Development

(iii)  PR5303 Good Regulatory Practices

(iv)  PR5213 Pharmaceutical Process Validation

(v)   PR5217 Formulation Science

(vi)  PR5218 Practical In Product Development – Lab rotation 

 

(b)  4 Elective Modules (To be chosen from any of the following; 16 
             MC) 

(i)   PR5211 Pharmaceutical Analysis IV

(ii)   PR5212 Advanced Topics in Medicinal Chemistry

(iii)  PR5214 Advances in Tablet Technology

(iv)  PR5216 Advances in Drug Delivery

(v)   PR5219 Product Quality Management 

As the programme progresses, the Department will introduce new modules to suit the changing needs of the pharmaceutical industry.   

Module Descriptions: 

PR3301       Pharmaceutical Dosage Forms

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. 

PR5211       Pharmaceutical Analysis IV

This module will introduce advanced NMR techniques and their applications to peptides, proteins and drug design. Students will understand the basic principles of fluorescence and its applications to peptides, proteins and their interactions, and also to understand the basic principles and pharmaceutical and biomedical applications of tandem techniques 

PR5212       Advanced Topics in Medicinal Chemistry

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. 

PR5213       Pharmaceutical Process Validation

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. 

PR5214       Advances in Tablet Technology

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

PR5216       Advances in Drug Delivery

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 

PR5217       Formulation Science

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. 

PR5218       Practical In Product Development

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) 

PR5219       Product Quality Management

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. 

PR5301       Food and Drug Laws

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. 

PR5302       Regulation of Drug Development

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. 

PR5303       Good Regulatory Practices

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.