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Abuse Liability Assessment
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The non-medical use and abuse of prescription drugs is a serious health concern. Assessments of abuse liability evaluate the likelihood that a drug may be abused and/or result in dependence once on the market. Coupled with preclinical and other clinical data, these assessments provide regulatory agencies with a scientific basis to schedule drugs.
Many drugs require preclinical and clinical assessment of their abuse and dependence potential. Such studies provide good agreement with actual abuse patterns observed later in clinical practice.
The abuse liability assessment is an essential component of effective drug development planning. DecisionLine is the world leader in conducting abuse liability assessment. We:
- Devise optimal clinical development strategies by assessing abuse liability potential in the early stages of drug development
- Assist in generating preclinical, human experimental abuse liability and clinical trial data for an NDA
- Proprietary software Scheduled Measurement System for efficient and optimal capture of pharmacodynamic endpoints
- Have a database of experienced drug users for rapid recruitment into studies
- Ensure rapid ethics approval and study completion
- Provide full data management and biostatistical support.
Access an archived version of our webinar Insights into Abuse Liability: Role in CNS Drug Development.
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In 2003, 6.3 million people in the U.S. abused prescription drugs such as pain relievers, sedatives, stimulants & tranquilizers
Types of misuse/abuse:
Crushing the drug & inhaling/snorting it for stronger effect
Dissolving the drug & injecting it as a liquid form into the bloodstream for fast results
Taking a larger-than-prescribed dose or taking the drug more frequently than prescribed
DecisionLine has more experience in abuse liability assessments than any institution in the world and is the only CRO conducting these studies.
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