CHEM 392 : Issues in Drug Design and Development


2020 Semester Two (1205) (15 POINTS)

Course Prescription

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.

Course Overview

CHEM 392 is a core course for students enrolled in BSc. Specialization in Medicinal Chemistry. 

This course will prepare students for advanced Medicinal and Pharmaceutical courses at the post-graduate level and for jobs in the pharmaceutical industry.

This course covers a broad range of issues that are important in the design, development and marketing of new pharmaceuticals. At the start of the course, students are introduced to the Ministry of Health's policies on drug regulatory framework and drug subsidies in New Zealand. This is followed by lectures given by patent attorneys on ways of protecting intellectual property and patent law in the pharmaceutical industry.  The course has a real emphasis on Good Manufacturing Practices (GMP) in the pharmaceutical industry which include  GMP polices, technical aspects applied to process development, process engineering and scale up of active pharmaceutical ingredients. Occupational health and safety issues as applied to the pharmaceutical industry are presented and discussed. The course has one lecture dedicated to the different aspects of clinical trials including formulation of a drug, phase I, phase II and phase III protocols and ethical considerations.  Examples of successful drug development exercises carried out in the University's research labs are given as 4-5 hours of lectures. Commercialization models  for intellectual property developed in the university setting are also covered in this course.

Course Requirements

Prerequisite: Minimum of 165 points passed

Capabilities Developed in this Course

Capability 1: Disciplinary Knowledge and Practice
Capability 2: Critical Thinking
Capability 3: Solution Seeking
Capability 4: Communication and Engagement
Capability 5: Independence and Integrity
Capability 6: Social and Environmental Responsibilities
Graduate Profile: Bachelor of Science

Learning Outcomes

By the end of this course, students will be able to:
  1. Understand and apply the many issues surrounding the conversion of a potential drug candidate into a marketed medicine. (Capability 1, 2, 3, 4, 5 and 6)
  2. Understand and explain intellectual property, patent laws and trade-marks as applied to pharmaceutical development (Capability 1, 2 and 3)
  3. Understand and describe how clinical trials on new drug candidates are designed and executed. (Capability 1 and 2)
  4. Understand and explain all ethical issues surrounding the discovery and development of pharmaceuticals. (Capability 1, 2 and 3)
  5. Understand and explain the classification of drugs and be able to relate the chemical structures to the different drug classes. (Capability 1 and 2)
  6. Understand and explain the role of Medsafe in pharmaceutical development in New Zealand. (Capability 1 and 2)
  7. Understand and explain the role of Pharmac in pharmaceutical development and the basis of drug subsidies in New Zealand. (Capability 1, 2 and 3)
  8. Conduct literature survey on an assigned topic and prepare a technical report based on instructions provided. (Capability 1, 2, 4, 5 and 6)
  9. Understand and explain Good Manufacturing Practices in pharmaceutical development including a basic definition of GMP and guidance relating to Quality Management to Buildings and Facilities, Materials Management and manufacture of APIs for use in Clinical Trials. (Capability 1, 2 and 3)


Assessment Type Percentage Classification
Test 20% Individual Test
Assignments 25% Individual Coursework
Reports 5% Individual Coursework
Final Exam 50% Individual Examination
Assessment Type Learning Outcome Addressed
1 2 3 4 5 6 7 8 9
Final Exam


Key Topics

Intellectual property and patenting as applied to pharmaceutical development.

Drug regulations and drug subsidies.

Good Manufacturing Practices in the pharmaceutical industry.

Process Engineering and Development in pharmaceutical development.

Examples of drug development exercises from academia and industry.

Ethical issues in pharmaceutical development.

Learning Resources

All course material will be available on Canvas .

Special Requirements

Site visit and report

Workload Expectations

This course is a standard 15 point course and students are expected to spend 10 hours per week involved in each 15 point course that they are enrolled in.

For this course, you can expect 32 hours of lectures,  20 hours of reading and thinking about the content and 37 hours of work on assignments and/or test preparation.

Digital Resources

Course materials are made available in a learning and collaboration tool called Canvas which also includes reading lists and lecture recordings (where available).

Please remember that the recording of any class on a personal device requires the permission of the instructor.


The content and delivery of content in this course are protected by copyright. Material belonging to others may have been used in this course and copied by and solely for the educational purposes of the University under license.

You may copy the course content for the purposes of private study or research, but you may not upload onto any third party site, make a further copy or sell, alter or further reproduce or distribute any part of the course content to another person.

Academic Integrity

The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework as a serious academic offence. The work that a student submits for grading must be the student's own work, reflecting their learning. Where work from other sources is used, it must be properly acknowledged and referenced. This requirement also applies to sources on the internet. A student's assessed work may be reviewed against online source material using computerised detection mechanisms.

Inclusive Learning

All students are asked to discuss any impairment related requirements privately, face to face and/or in written form with the course coordinator, lecturer or tutor.

Student Disability Services also provides support for students with a wide range of impairments, both visible and invisible, to succeed and excel at the University. For more information and contact details, please visit the Student Disability Services’ website at

Special Circumstances

If your ability to complete assessed coursework is affected by illness or other personal circumstances outside of your control, contact a member of teaching staff as soon as possible before the assessment is due.

If your personal circumstances significantly affect your performance, or preparation, for an exam or eligible written test, refer to the University’s aegrotat or compassionate consideration page:

This should be done as soon as possible and no later than seven days after the affected test or exam date.

Student Feedback

During the course Class Representatives in each class can take feedback to the staff responsible for the course and staff-student consultative committees.

At the end of the course students will be invited to give feedback on the course and teaching through a tool called SET or Qualtrics. The lecturers and course co-ordinators will consider all feedback.

Your feedback helps to improve the course and its delivery for all students.

Student Charter and Responsibilities

The Student Charter assumes and acknowledges that students are active participants in the learning process and that they have responsibilities to the institution and the international community of scholars. The University expects that students will act at all times in a way that demonstrates respect for the rights of other students and staff so that the learning environment is both safe and productive. For further information visit Student Charter (


Elements of this outline may be subject to change. The latest information about the course will be available for enrolled students in Canvas.

In this course you may be asked to submit your coursework assessments digitally. The University reserves the right to conduct scheduled tests and examinations for this course online or through the use of computers or other electronic devices. Where tests or examinations are conducted online remote invigilation arrangements may be used. The final decision on the completion mode for a test or examination, and remote invigilation arrangements where applicable, will be advised to students at least 10 days prior to the scheduled date of the assessment, or in the case of an examination when the examination timetable is published.

Published on 20/07/2020 11:33 a.m.