WEbCAST series - are you taking an integrated approach?
Any prescription medicine has the potential to be abused, however, drug products affecting the Central Nervous System (CNS) and those able to produce rewarding psychoactive effects are considered to be at greater risk of being misused. As a result, preclinical evaluations of the abuse potential of new drugs affecting the CNS are an integral component of new drug applications (NDA).
In this two-part webcast series independent Consultant, Mary Jeanne Kallman and Evotec Research Leader, Abuse Liability, Michela Tessari will present practical and methodological approaches to preclinical drug abuse liability assessment of novel CNS-active candidates in light of International Regulatory Agencies' recommendations.
Experts will discuss a number of critical parameters that should be carefully considered when designing animal behavioural studies to investigate the abuse potential of novel compounds.
Part one | Abuse Liability Assessment of new drugs from candidate selection to New Drug Application
Part two | Abuse Liability Assessment of new drugs: core preclinical studies to address regulatory requirements
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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.