# MEDSCI 719 : Pharmacometrics

## Medical and Health Sciences

### Course Prescription

An introduction to the application of mathematical models used in the interpretation of pharmacological observations. Computer-based analysis methods are investigated using individual and population-oriented approaches.

### Course Overview

Pharmacometrics is the science of applying quantitative principles to interpret pharmacological observations. Specifically, pharmacometrics involves the use of mathematical and statistical models to quantify drug properties and physiological processes, usually with consideration of time. The science of pharmacometrics requires a theoretical understanding of pharmacology concepts as well as statistics and skills in coding and computer software. Pharmacometricians are involved in all parts of the development and clinical use pathway of pharmaceutical products, and have varied roles in regulatory, academic and industry.

The course is a mix of theory and practice. Students learn the fundamentals of modelling pharmacological processes using examples from pharmacokinetics and pharmacodynamics in a small group environment. The methods taught have wide application in all areas of medical and biological science. This course would suit students with a good foundation in pharmacokinetics and pharmacodynamics, and some experience in statistics. It involves computer-based analysis and so familiarity with software such as Excel and R (although not required) is useful.

### Course Requirements

No pre-requisites or restrictions

### Course Contacts

Course Director:
Dr Jacqueline Hannam
503-302-J, Ext 82869, j.hannam@auckland.ac.nz

### Capabilities Developed in this Course

 Capability 3: Knowledge and Practice Capability 4: Critical Thinking Capability 5: Solution Seeking Capability 6: Communication Capability 8: Ethics and Professionalism

### Learning Outcomes

By the end of this course, students will be able to:
1. Explain and apply key principles of pharmacology to describe pharmacological data in mathematical models (Capability 3 and 5)
2. Design, implement and optimise models for observations of the time course of drug concentration and response (Capability 3, 4 and 5)
3. Critique and evaluate their own models for simulation and parameter estimation (Capability 3, 4 and 5)
4. Summarise an appropriate modelling procedure, outlining how this is driven by the aims of the analysis (Capability 3, 4 and 6)
5. Articulate and critically examine findings in context of literature data and modelling results (Capability 3, 4 and 6)
6. Actively engage and participate in class discussion on pharmacological theory and modelling methods (Capability 6 and 8)
7. Demonstrate capability in using Excel and common simulation and modelling software used in pharmacometric analyses (Capability 3)
8. Be able to identify and explain models that describe variability and how these relate to subjects, observations and model predictions (Capability 3)

### Assessments

Assessment Type Percentage Classification
Reports 60% Individual Coursework
Assignments 35% Individual Coursework
Presentation 5% Individual Coursework
1 2 3 4 5 6 7 8
Reports
Assignments
Presentation

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: 22 hours of workshops; 2 hours of laboratory work; 45 hours of reading and thinking about the content and the workshop material; and 81 hours of work on reports, assignments and/or presentation preparation.

### Delivery Mode

#### Campus Experience

Attendance is expected at scheduled activities including workshops and the lab to complete components of the course.
Workshops will be available as recordings. The lab will not be available as recordings.
The course will not include live online events.
Attendance on campus is not required for the assignment.
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.

We do not recommend the purchase of any one particular textbook to support course content. However, you may nd the following resources useful for helping with reports or for background reading for the workshop material:

Mould, D. and Upton, R. (2012), Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development. CPT: Pharmacometrics & Systems Pharmacology, 1: 1-14 6. https://doi.org/10.1038/psp.2012.4

Mould, D. and Upton, R. (2013), Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development—Part 2: Introduction to Pharmacokinetic Modeling Methods. CPT: Pharmacometrics & Systems Pharmacology, 2: 1-14 38. https://doi.org/10.1038/psp.2013.14

Owen, Joel S., and Fiedler-Kelly, Jill. Introduction to Population Pharmacokinetic/pharmacodynamic Analysis with Nonlinear Mixed Effects Models. 2014. Web. (Available online through University of Auckland library)

Bonate P.L. Pharmacokinetic-pharmacodynamic modeling and simulation. Springer. New York, 2005 (Available in hard copy through University of Auckland library)

### Student Feedback

At the end of every semester 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 and respond with summaries and actions.

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

Class Representatives in each class can take feedback to the department and faculty staff-student consultative committees.

Course enrolments are typically too low for this course to qualify for SET however feedback directly from students and student reps (where appointed) is routinely sought, and valuable information on the learning resources and assessments acted upon.

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.

### 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 .

### Disclaimer

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.