CHEM 392 : Issues in Drug Design and Development


2024 Semester Two (1245) (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. Students are introduced to the Ministry of Health's policies on drug regulatory framework and how Pharmac decides on drug subsidies in New Zealand. There is then  a module of 5-6 lectures given by patent attorneys on ways of protecting intellectual property and patent law in the pharmaceutical industry as well as litigation. We then cover new ways in which drugs are discovered and have a lecture on biological drugs-a fast growing and very lucrative area.
 The course has a emphasis on Good Manufacturing Practices (GMP) in the pharmaceutical industry which includes GMP policies, technical aspects applied to process development delivered by Douglas Pharmaceuticals as well as  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 2-3 lectures dedicated to the different aspects of clinical trials including design of clinical trials, drug formulation and ethical considerations. Several examples of successful -FDA approved drugs and their development carried out in the University's research labs are given as 4-5 hours of lectures by scientists in the field. Commercialization models for intellectual property developed in the university setting are also covered in this course.

Course Requirements

Prerequisite: CHEM 110 and a further 150 points passed

Capabilities Developed in this Course

Capability 1: People and Place
Capability 2: Sustainability
Capability 3: Knowledge and Practice
Capability 4: Critical Thinking
Capability 5: Solution Seeking
Capability 6: Communication
Capability 8: Ethics and Professionalism
Graduate Profile: Bachelor of Science

Learning Outcomes

By the end of this course, students will be able to:
  1. Describe the many issues surrounding the conversion of a potential drug candidate into a marketed medicine. (Capability 1, 2, 3, 4, 5 and 6)
  2. Describe and explain intellectual property, patent laws and trade-marks as applied to pharmaceutical development (Capability 1, 3 and 8)
  3. Describe and explain how clinical trials on new drug candidates are designed and executed. (Capability 3 and 8)
  4. Describe all ethical issues surrounding the discovery and development of pharmaceuticals. (Capability 1, 4 and 8)
  5. Describe the classification of drugs and be able to relate the chemical structures to the different drug classes. (Capability 3 and 4)
  6. Explain the role of Medsafe in pharmaceutical development in New Zealand. (Capability 1 and 3)
  7. Explain the role of Pharmac in pharmaceutical development and the basis of drug subsidies in New Zealand. (Capability 1 and 3)
  8. Conduct research and literature survey on an assigned topic and prepare a technical report based on instructions provided. (Capability 2, 3, 4, 5, 6 and 8)
  9. 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 2 and 3)


Assessment Type Percentage Classification
Test 15% Individual Test
Assignments 25% Individual Coursework
Reports 5% Individual Coursework
Final Exam 50% Individual Examination
Quizzes 5% Individual Coursework
Assessment Type Learning Outcome Addressed
1 2 3 4 5 6 7 8 9
Final Exam


Tuākana Science is a multi-faceted programme for Māori and Pacific students providing topic specific tutorials, one-on-one sessions, test and exam preparation and more. Explore your options at

As part of the University-wide Tuākana community, The School of chemical sciences aims to provide a welcoming learning environment for and enhance the success of, all of our Māori and Pacific students. We are led by the principles of tautoko (support) and whanaungatanga (connection) and hope you find a home here at the School. Students who have identified as Māori and/or Pacific will receive an invitation to our online portal introducing the Programme, the resources we have available, and how you can get involved.

Tuākana Chemistry runs a range of activities for students enrolled in this class. This includes weekly workshops, social activities, and opportunities to engage with senior students and researchers within the School of Chemical Sciences. Tuākana-eligible students will be added automatically to the Tuākana Chemistry program when they enroll in this course. For more information, please see the Tuākana program website or email

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.
  • Clinical trials and ethical issues in pharmaceutical development.

Special Requirements

Attendance at the site visit is a compulsory part of this course. Students must be wearing safety glasses, covered footwear, and a lab coat before entering the manufacturing sites and must keep these on until after exiting. Jandals or other open shoes are not satisfactory footwear. Students who wear prescription spectacles are required to wear safety glasses over their spectacles. Students must comply with all health and safety regulations whilst at the site visits.

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.

Delivery Mode

Campus Experience

Attendance is required at scheduled activities including site visits to receive credit for components of the course.

Lectures will be available as recordings. Other learning activities will not be available as recordings.

The course will not include live online events.

Attendance on campus is required for the test and exam.

The activities for the course are scheduled as a standard weekly timetable.

Learning 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.

All course material will be available on Canvas

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.

No changes requried

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 for potential plagiarism or other forms of academic misconduct, using computerised detection mechanisms.

Class Representatives

Class representatives are students tasked with representing student issues to departments, faculties, and the wider university. If you have a complaint about this course, please contact your class rep who will know how to raise it in the right channels. See your departmental noticeboard for contact details for your class reps.


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.

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

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.

Learning Continuity

In the event of an unexpected disruption, we undertake to maintain the continuity and standard of teaching and learning in all your courses throughout the year. If there are unexpected disruptions the University has contingency plans to ensure that access to your course continues and course assessment continues to meet the principles of the University’s assessment policy. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator/director, and if disruption occurs you should refer to the university website for information about how to proceed.

The delivery mode may change depending on COVID restrictions. Any changes will be communicated through Canvas.

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 students may be asked to submit 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. In exceptional circumstances changes to elements of this course may be necessary at short notice. Students enrolled in this course will be informed of any such changes and the reasons for them, as soon as possible, through Canvas.

Published on 17/10/2023 08:02 a.m.