Drug abuse is defined as the intentional, non-therapeutic use of a drug product or substance, even once, to achieve a desired psychological or physiological effect. Therefore, abuse potential refers to the likelihood that abuse will occur with a particular drug product or substance with CNS activity. Regulators require a non-clinical assessment to be carried out on any new CNS active drug as part of a broader assessment of its abuse potential before market authorisation can be granted.
Sygnature scientists have extensive experience in assessing abuse potential and designing integrated non-clinical packages that will satisfy both sponsor and regulatory requirements in Europe, the US and Asia. These will include GLP-compliant self-administration and drug discrimination studies, as well as assessments of physical dependence and withdrawal. If beneficial, there is also the flexibility to add further mechanistic studies to compliment the regulatory package, using techniques such as microdialysis, neurofunctional assessments and receptor occupancy.
Importantly, our scientists’ long-standing expertise and drug development backgrounds position them perfectly to advise clients on meeting regulatory expectations and business objectives.
|Regulatory package||Models and Consultancy Services|
|Non-clinical assessment of abuse potential for CNS-active drugs (GLP compliant)||Intravenous self-administration|
|Physical dependence and withdrawal|
|Consultancy: Study design and regulatory strategy|
Early Assessment of Abuse Potential:
- Sygnature offers a battery of tests that can be used to explore the pharmacological profiles of novel drugs compared to known drugs of abuse, allowing the early assessment of abuse potential.
Our Core Values:
- Consultative approach and regulatory strategic advice
- Focus on high quality data and science-driven decision making
- Rapid study start-up process
- Dedicated and dynamic project team
- Collaborative customer relationships