Drug Abuse Potential: A Data Analysis Strategy for Nonclinical Self-Administration Studies

Clinical Trials, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Tuesday, November 20, 2018 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

If a drug compound (or its metabolites) crosses the blood-brain barrier, then the FDA requires an Abuse Potential Assessment, which includes GLP self-administration, drug discrimination and physical dependency studies. For some drug classes like stimulants (i.e. amphetamine and cocaine), self-administration studies have been widely characterized in several species with the corresponding data analysis being fairly straightforward.

For other drug classes, however, such as sedatives (i.e. phenobarbital, pentobarbital, midazolam), a greater degree of variability between animals and test sessions exists, along with a relatively low self-administration response. As a result, standard statistical analysis typically used to analyze self-administration studies is either too sensitive or not sensitive enough to support characterization of the biological response for this class of drugs.

This webinar will present a holistic data analysis strategy for nonclinical self-administration studies, taking into account patterns of response to provide a greater degree of characterization of the reinforcement properties of a drug. Throughout the webinar, featured speakers will provide sample data of this approach from known drugs of abuse including amphetamine, midazolam, ketamine and diamorphine.

Speakers

Sharon Rowton, PhD, Scientific Specialist, Covance

Sharon Rowton, PhD, has more than 30 years of pharmacology experience (specializing in behavioural/CNS work) gained within contract research organizations. During this time, Dr. Rowton has worked with a diverse range of compounds from various pharmacological classes, including opioids, cannabinoids, stimulants and benzodiazepines. Since 2015, Dr. Rowton has led the Drug Abuse-Related Studies service line, providing scientific guidance, operational oversight and strategy development for studies that evaluate the abuse liability of drugs that act on the central nervous system (CNS) for regulatory submission.

Message Presenter

Kelly Ashcroft-Hawley, MMath, Principal Statistician, Covance

Kelly Ashcroft-Hawley, MMath, is a Principal Statistician at Covance with more than 12 years of experience in nonclinical statistics. During this time, she has worked across all areas of early development supporting studies in toxicology, safety pharmacology, genetic toxicology, immunochemistry and biopharm-CMC. Since 2015, Kelly has specialized in the statistical analysis of safety pharmacology endpoints.

Message Presenter

Who Should Attend?

Individuals involved in the development of compounds that penetrate the CNS, regardless of therapeutic indication, from:

  • Pharma
  • Consultancy

Involved in the following fields:

  • Nonclinical development
  • Clinical development
  • Data analysis

What You Will Learn

  • The challenges associated with evaluating data from self-administration studies
  • The importance of taking a holistic approach to the analysis of data from self-administration studies
  • The importance of study design

Xtalks Partner

Covance

Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®.

Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Information on Covance’s solutions can be obtained through its website at www.covance.com.

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