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Course profile

Pre-clinical Drug Development (PHIP7122)

Study period
Sem 2 2024
Location
Dutton Park
Attendance mode
In Person

Course overview

Study period
Semester 2, 2024 (22/07/2024 - 18/11/2024)
Study level
Postgraduate Coursework
Location
Dutton Park
Attendance mode
In Person
Units
4
Administrative campus
Dutton Park
Coordinating unit
Pharmacy School

Students taking this course will have the opportunity to engage in experimental and theoretical skill development in pharmaceutical analysis and quality assurance in pharmaceutics. They will also be exposed to the intricacies of pre-clinical research, how research uses animal models and the ethical boundaries. The course will provide highlight the role of pharmacodynamics, pharmacokinetics and toxicology as well as emphasise the need for collection of safety data in the early stages of drug development. Students will learn about the type of and need for recording results and the documentation. The students will meet a career professional and learn about the practical application of the knowledge gained within the course. The theoretical aspects of the course are supported by a large pharmaceutical analysis and pharmaceutical quality assurance individual research project that involves analysis of drug concentrations using industry standard techniques with an emphasis on analytical design, method development and interpretation of findings both in report form and oral defence.

Welcome to the course profile for PHIP7122, a part of the Masters of Pharmaceutical Industry Practice. Please email or see the course co-ordinator for any questions you have regarding the course information.

Course requirements

Restrictions

MPharmIndPrac students only

Course contact

Course staff

Lecturer

Guest lecturer

Dr Fekade Sime

Tutor

Mr Yifan Wang
Mr Junkai Zhang
Ms Min-Tz Weng
Dr Fekade Sime

Timetable

The timetable for this course is available on the UQ Public Timetable.

Additional timetable information

All timetable information will be detailed in the blackboard site for this course.

Aims and outcomes

This course aims to develop your knowledge and capacity in perspectivesᅠof the general theme ofᅠpreclinical drug discovery, with a specific focus on: preclinical drug and device discovery, animal ethics, pharmacokinetics, pharmacodynamics, toxicology, qualitiy assurance in pharmaceuticals, drug analysis, research learning, and communicating science.

Learning outcomes

After successfully completing this course you should be able to:

LO1.

Contextualise the role Preclinical Drug Discovery has in the drug life cycle

LO2.

Identify and explain the role of toxicology in light of preclinical and clinical drug evaluation

LO3.

Apply the principles of pharmacodynamics and pharmacokinetics

LO4.

Justify the role of animal research and the ensuing ethical considerations and regulatory processes

LO5.

Collaborate and apply skills in research learning

LO6.

Design and deliver a presentation on scientific research

Assessment

Assessment summary

Category Assessment task Weight Due date
Presentation, Poster Poster Presentation of Preclinical Research
  • Identity Verified
  • In-person
  • Online
20%

19/08/2024 - 26/08/2024

The poster will be submitted prior to the poster presentation session, and the same poster will be presented at the assigned time. Workshop sessions will be used for presentation times. Please refer to the schedule in the Blackboard site timetable.

Paper/ Report/ Annotation Pharmaceutical Analysis Research Project Report
20%

2/09/2024 3:00 pm

Quiz Pharmacokinetic and Pharmacodynamic Online Quiz
  • Online
10%

13/09/2024 3:00 pm

The quiz will be be opened 7 days before the due date.

Quiz Toxicology Quiz
  • Online
10%

16/09/2024 3:00 pm

The quiz will be be opened 7 days before the due date.

Paper/ Report/ Annotation, Project Quality Assurance Research Project
  • Team or group-based
40%

4/11/2024 3:00 pm

Assessment details

Poster Presentation of Preclinical Research

  • Identity Verified
  • In-person
  • Online
Mode
Oral, Product/ Artefact/ Multimedia
Category
Presentation, Poster
Weight
20%
Due date

19/08/2024 - 26/08/2024

The poster will be submitted prior to the poster presentation session, and the same poster will be presented at the assigned time. Workshop sessions will be used for presentation times. Please refer to the schedule in the Blackboard site timetable.

Learning outcomes
L01, L02, L04, L06

Task description

The poster presentation will focus on preclinical drug discovery topics, including in vitro and in vivo research methods for various diseases, on a topic that will be assigned to each student.

  • A single PowerPoint slide as an electronic poster will be submitted prior to the assigned poster presentation session.
  • The poster will be presented within the poster presentation session during a scheduled workshop.
  • Further details for slide preparation and presentation schedule will be provided on Blackboard.
  • This task is assessed by two rubrics: one for the oral presentation and one for the poster. 50% of marks are allocated to each assessment.

The presentation will be recorded and retained as per university policy. The recording will be stored in a secure manner and will only be accessed if required for the purposes of moderation of marking; provision of feedback to the student; and/or re-marking following a successful re-mark application.

This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) technologies, successful completion of assessment in this course will require students to critically engage in specific contexts and tasks for which artificial intelligence will provide only limited support and guidance. To pass this assessment, students will be required to demonstrate detailed comprehension independent of AI tools.

Submission guidelines

The poster file is to be submitted via Blackboard before the presentation, and the presentation will be in class as scheduled on the Blackboard site.

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

Pharmaceutical Analysis Research Project Report

Mode
Written
Category
Paper/ Report/ Annotation
Weight
20%
Due date

2/09/2024 3:00 pm

Other conditions
Student specific.

See the conditions definitions

Learning outcomes
L05

Task description

The pharmaceutical analysis research project report requires students to analyse a data pack in the form of an excel document (unique to each individual student, assigned by student number). The data pack includes data from a simulated experiment analysing the active ingredient in a set of tablets in which the students will use a graphing program, GraphPad Prism, to determine the contents of the active ingredient within the data set and comment on whether it passes the test. The related tutorial session will cover the methods of analysis. The tasks for the report will be found on blackboard.

This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) and Machine Translation (MT) technologies, successful completion of the assessment will require students to critically engage in specific contexts and tasks for which AI will provide only limited support and guidance. A failure to reference AI or MT use may constitute student misconduct under the Student Code of Conduct. To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI and MT tools.

Submission guidelines

Submission via Turnitin link provided in the Blackboard site.

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

Pharmacokinetic and Pharmacodynamic Online Quiz

  • Online
Mode
Written
Category
Quiz
Weight
10%
Due date

13/09/2024 3:00 pm

The quiz will be be opened 7 days before the due date.

Other conditions
Time limited.

See the conditions definitions

Learning outcomes
L03

Task description

The quiz will assess the content from the Pharmacokinetics and Pharmacodynamics module within the course.

  • One attempt is permitted for this quiz.
  • The quiz duration is 30 minutes. An additional 15 minutes is provided as a buffer for any issues that might arise during your quiz.
  • The format may be a mixture of question types, for example: multiple choice, multiple answer, matching, ordering, fill in the blank/s, jumbled sentence/s, either/or (e.g. true/false), short answer, and short essay style questions.
  • Questions may be provided randomly from a pool, therefore each student may receive a different but equivalent quiz.
  • The quiz will be marked electronically, correct answers will be awarded the marks indicated beside the question, and incorrect answers will be awarded zero.
  • This is an individual assessment that you are required to undertake without any form of communication with other students.

Submission guidelines

Complete the quiz online via the Link provided at Learn.UQ (Blackboard) any time in the 7 days prior to the submission deadline.

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

Toxicology Quiz

  • Online
Mode
Written
Category
Quiz
Weight
10%
Due date

16/09/2024 3:00 pm

The quiz will be be opened 7 days before the due date.

Other conditions
Time limited.

See the conditions definitions

Learning outcomes
L02

Task description

The quiz will assess the content from the toxicology module within the course.

  • One attempt is permitted for this quiz.
  • The quiz duration is 30 minutes. An additional 15 minutes is provided as a buffer for any issues that might arise during your quiz.
  • The format may be a mixture of question types, for example: multiple choice, multiple answer, matching, ordering, fill in the blank/s, jumbled sentence/s, either/or (e.g. true/false), short answer, and short essay style questions.
  • Questions may be provided randomly from a pool, therefore each student may receive a different but equivalent quiz.
  • The quiz will be marked electronically, correct answers will be awarded the marks indicated beside the question, and incorrect answers will be awarded zero.
  • This is an individual assessment that you are required to undertake without any form of communication with other students.

Submission guidelines

Complete the quiz online via the Link provided at Learn.UQ (Blackboard) any time in the 7 days prior to the submission deadline.

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

Quality Assurance Research Project

  • Team or group-based
Mode
Written
Category
Paper/ Report/ Annotation, Project
Weight
40%
Due date

4/11/2024 3:00 pm

Other conditions
Peer assessment factor.

See the conditions definitions

Learning outcomes
L05

Task description

The detailed task requirements can be found on the Blackboard site. The Quality Assurance research project will be based on what was conducted during the practical sessions, where British Pharmacopeia assessments will be performed on pharmaceutical tablets. The results from the practical will be presented within the report and assessed against the rubrics provided on the Blackboard site. Reports are required to address the tasks described in the practical guide and the rubric attached to the Blackboard site. One report is to be submitted by each team, and team members are responsible for ensuring submission is completed.

The assessment is divided into three parts: the project report (30% of semester marks submitted as a group), the laboratory records submitted as an individual and assessed as an individual (5% of the semester), and the peer contribution assessment (5% of the semester).

This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) and Machine Translation (MT) technologies, successful completion of the assessment will require students to critically engage in specific contexts and tasks for which AI will provide only limited support and guidance. A failure to reference AI or MT use may constitute student misconduct under the Student Code of Conduct. To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI and MT tools.

Submission guidelines

Submission via Blackboard for peer mark and report. Laboratory books submission via office.

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Late submission

A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.

Course grading

Full criteria for each grade is available in the Assessment Procedure.

Grade Cut off Percent Description
1 (Low Fail) 1 - 29

Absence of evidence of achievement of course learning outcomes.

2 (Fail) 30 - 44

Minimal evidence of achievement of course learning outcomes.

3 (Marginal Fail) 45 - 49

Demonstrated evidence of developing achievement of course learning outcomes

4 (Pass) 50 - 64

Demonstrated evidence of functional achievement of course learning outcomes.

5 (Credit) 65 - 74

Demonstrated evidence of proficient achievement of course learning outcomes.

6 (Distinction) 75 - 84

Demonstrated evidence of advanced achievement of course learning outcomes.

7 (High Distinction) 85 - 100

Demonstrated evidence of exceptional achievement of course learning outcomes.

Supplementary assessment

Supplementary assessment is available for this course.

Learning resources

You'll need the following resources to successfully complete the course. We've indicated below if you need a personal copy of the reading materials or your own item.

Library resources

Find the required and recommended resources for this course on the UQ Library website.

Other course materials

If we've listed something under further requirement, you'll need to provide your own.

Required

Item Description Further Requirement
Laboratory coat For your health and safety, you will not be allowed to enter the laboratory without this item. Laboratory coats can be acquired from the School Locker on the St Lucia campus or relevant scientific health and safety stores. own item needed
Laboratory safety glasses For your health and safety, you will not be allowed to enter the laboratory without this item. Laboratory safety glasses can be acquired from the School Locker on the St Lucia campus or relevant scientific health and safety stores. own item needed

Additional learning resources information

Zoom: Access to Zoom via your UQ student account will be required for certain synchronous online classes each week (workshops).

Learning activities

The learning activities for this course are outlined below. Learn more about the learning outcomes that apply to this course.

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Learning period Activity type Topic
Multiple weeks

From Week 1 To Week 2

Workshop

Preclinical Drug Discovery and Animal Ethics

Learning outcomes: L01, L04, L06

Multiple weeks

From Week 3 To Week 7

Workshop

Pharmacokinetics

Learning outcomes: L01, L05

Multiple weeks

From Week 6 To Week 8

Workshop

Toxicology

Learning outcomes: L02

Multiple weeks

From Week 6 To Week 13

Practical

Pharmaceutical Analysis and Quality Assurance

Practicals are held on Wednesday in Week 6 and Weeks 10-13. These sessions will be laboratory based and requires personal protective equipment such as laboratory coat and laboratory safety glasses. The practicals will involve quality assurance assays on pharmaceutical tablets. The practicals are split into two sessions: morning (9am to 12pm) and afternoon (2pm to 5pm). Students will work in groups and submit a group assignment report outlined in the assessment section (Quality Assurance Research Project). Specific dates, time and location are detailed on Blackboard.

Learning outcomes: L01, L05

Multiple weeks

From Week 9 To Week 11

Workshop

Industry Expert Engagement

Workshops with Industry experts relevant to the course, presented by the guest lecturer.

Learning outcomes: L01, L02, L03

Policies and procedures

University policies and procedures apply to all aspects of student life. As a UQ student, you must comply with University-wide and program-specific requirements, including the:

Learn more about UQ policies on my.UQ and the Policy and Procedure Library.

You'll also need to be aware of the following policies and procedures while completing this course:

  • Laboratory Occupational Health and Safety