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Webinar | Abuse Liability Assessment of new drugs: core preclinical studies to address regulatory requirements
Preclinical evaluations of the abuse potential of new drugs affecting the Central Nervous System (CNS) are an integral component of new drug applications.
This informative webinar will present practical and methodological approaches to preclinical assessment of liability testing of novel CNS-active candidates in light of International Regulatory Agencies recommendations. A number of critical parameters that should be carefully considered when designing animal behavioural studies to investigate the abuse potential of novel compounds will be discussed.
Key discussion points of the webinar:
- Regulatory requirements: preclinical species, test doses, behavioural test designs, test conditions, comparators
- Core preclinical studies - methods and examples
About the speakers
Mary Jeanne Kallman PhD, DSP
Mary Jeanne frequently publishes scientific papers, book chapters, and presents on various CNS issues. She received EPA and NIH funding for her research and support of her academic laboratory.
Michela Tessari | Research Leader, Abuse Liability, Global Preclinical Development, Evotec
Michela is an experienced pharmaceutical scientist with a strong expertise in the drug dependence field. She has contributed to many programmes as an in-vivo pharmacologist responsible for the behavioural assays (pharmacodynamic and disease) in rodents with relevance for multiple CNS disease areas. She has led the implementation of GLP regulations in the conduction of behavioural studies for the investigation of abuse potential.
Michela is a member of the Safety Pharmacology Society.