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
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.
