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
Degree list
The following degrees include this course