Welcome to Module 4. Preclinical Development
Turning a repurposing candidate into a market ready therapy, targeted to patient need, is a complex process. A thorough understanding of your compound, its properties, and interactions is integral to this success.
Preclinical research, sometimes called non-clinical research, plays a crucial role in drug development: it evaluates the safety, efficacy, and pharmacological properties of potential therapeutic agents before they advance to clinical trials in humans (see Module 5: Clinical Development).
When it comes to drug repurposing, preclinical development involves several target identification and validation steps (building on some of the topics covered in Module 3: Finding a Repurposing Candidate), including:
- In vitro studies – conducted outside of a living organism, e.g. in a test tube
- In vivo studies – conducted within a living organism
- Dose finding and optimisation studies – designed to identify tolerable therapeutic doses for a new medication
- Pharmacokinetics studies – helping to understand the behaviour and movement of a drug substance within the body
- Safety assessment – to identify the risks, side effects and interactions of a drug in the body
- Regulatory approval – demonstrating sufficient evidence to suggest a clinical trial is safe, and has potential benefit to the target population
Overall, preclinical development in drug repurposing involves a systematic and rigorous evaluation process to ensure the successful transformation of a molecule into a targeted patient ready therapy.
The learning objectives of this module are to:
- Have a comprehensive overview of the preclinical development process in drug repurposing
- Better understand the complexity and multifaceted approach needed in preclinical development, including understanding different experimental techniques and strategies, regulatory standards, patient-related and market considerations.
Click on the topics in the panel on the right to navigate through the content. Do not forget to click ‘mark as complete’ at the bottom of each page to track your progress.
Good luck on your repurposing journey!
Acknowledgements
Primary author: Claudia Fuchs (EURORDIS)
Reviewers: Abby Stock-Duerdoth, Johanna Huchting and Philip Gribbon
We’ve worked hard to bring this module to life, aiming to make it comprehensive and valuable for you. Because this is the very first launch of the Digital Academy, we really need your feedback. Please take a moment to complete our 3-minute feedback form at the end—we’d love to hear your thoughts!
