Course overview
The aim of this course is to provide an in-depth knowledge of the toxicities associated with drug development, including processes of discovery, design, development, preclinical testing and clinical trials of novel drugs. Overview the need, procedures and processes involved in drug design and development for clinical trials; provide specific examples of where toxicology issues can arise; developing compounds to act on a target and identifying potential off-target interactions of compounds and the specific toxic effects that may arise; regulated manufacturing of compounds; pre-clinical studies (including high-throughput screening and animal models) focussing on safety; research ethics (animal and human) and the importance of monitoring and reporting; moving from pre-clinical to clinical trials and safety approvals required; importance of capturing toxicity data from clinical trials.
Course learning outcomes
- Describe the potential sources of adverse effects of novel treatment strategies.
- Demonstrate the concepts of testing drugs and their targets with respect to safety in a laboratory setting.
- Design and explain the concepts behind novel compounds targeting disease pathways and how else these pathways impact normal physiology.
- Explain methods of safety-profiling related to drug-development from pre-clinical to clinical trials with new drugs, including safety approvals required, procedures and study design to screen for and capture toxicity, and the potential flaws and level of evidence from toxicity profiles obtained from clinical trials.
- Explain the impact of toxicities on clinical trials participants and/or patients receiving new therapies.