Non-Clinical Studies for Clinical Trials

Undergraduate | 2026

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Area/Catalogue
PHAR 2001
Course ID icon
Course ID
201300
Level of study
Level of study
Undergraduate
Unit value icon
Unit value
6
Course level icon
Course level
2
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Inbound study abroad and exchange
Inbound study abroad and exchange
The fee you pay will depend on the number and type of courses you study.
Yes
University-wide elective icon
University-wide elective course
Yes
Single course enrollment
Single course enrolment
Yes
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Note:
Course data is interim and subject to change

Course overview

This course will provide an understanding of the non-clinical aspects which support the conduct of clinical trials. The content will focus on the in vitro and in vivo pharmacology and toxicology studies which support the transition to first-in-human trials and will build on knowledge gained in the clinical trials foundational course. An overview of the bioanalytical and manufacturing processes that support the conduct of early and late phase clinical trials will also be provided, as well as an understanding of the ethical and regulatory frameworks governing non-clinical studies. This course aligns with the program intent to establish foundational knowledge and skills relevant to biomedical and health sciences.

Course learning outcomes

  • Demonstrate an understanding of the design and analysis of non-clinical in vitro and in vivo studies to support drug development
  • Describe the importance of bioanalytical approaches to support studies within the non-clinical and clinical development programs
  • Identify the procedures used to assess the physical and chemical characteristics of drug products to ensure their quality and consistency during manufacturing
  • Demonstrate an understanding of the standards which govern the conduct of non-clinical studies

Prerequisite(s)

N/A

Corequisite(s)

N/A

Antirequisite(s)

N/A