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Abuse Liability Assessment of New Drugs from Candidate Selection to New Drug Application
Prescription drug abuse is a growing global challenge that underlines the importance of assessing the abuse potential of pharmaceutical products and implementing measures designed to control their non-medical use. New drug applications (NDA) for medications that could affect the central nervous system must include an assessment of their potential for abuse.
This webinar will explain what pharmaceutical drug abuse liability assessment implies and which factors must be taken into consideration when approaching these studies in light of the regulatory requirements. Given the complexity of the scheduling process, and the experimental subtleties that can impact on preclinical and clinical studies used to support a drug’s schedule, it is essential that abuse liability investigations are designed with the utmost care. An integrated approach in the earliest stages of development can provide valuable benefits in terms of timelines and likelihood of success.
Key discussion points of the webinar:
- Regulatory environment of abuse potential of CNS active compounds under development
- Scheduling process and implications
- Critical steps and decision points for the assessment of abuse potential of CNS active compounds
- Tiered approach: overview of core preclinical studies
About the Speakers
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