Thursday, November 12
11:00 AM–2:30 PM
(Eastern Standard Time)
CE01—Practical Considerations in Experimental Design for In Vivo Studies
When assigned to complete their first in vivo toxicology study or studies, toxicologists sometimes do not know where to start the study design. Read more.
CE02—Nonclinical Respiratory Assessments: Techniques, Challenges, and Regulatory Insights
There are many unique challenges to developing therapeutics via the respiratory route. Read more.
CE03—To Hold or Not to Hold? Regulator and Sponsor Perspectives on Difficult FIH Toxicology Packages
First-in-human (FIH) clinical trials rely heavily on nonclinical data for safety assessment. Read more.
CE04—Applied Toxicology in Veterinary Drug Development
Safety assessment in veterinary drug development involves unique regulatory requirements, necessitating the application of several fields of toxicology. Read more.
CE05—Introduction to Humanized Mice and Their Potential Application
Humanized mice are chimeric animals made by injecting/implanting human cells/tissues into severely immune-compromised mice. Read more.
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Friday, November 13
11:00 AM–2:30 PM
(Eastern Standard Time)
CE06—Nonclinical/Toxicology Study Contracting and Monitoring: Practical Considerations
This course will provide the attendee with practical guidance for designing, contracting, monitoring, and reporting nonclinical/toxicology studies. Read more.
CE07—Understanding the Assessment of Abuse Potential: Industry and Regulatory Perspective
As America continues to struggle with the opioid epidemic, it is more prudent than ever to ensure the abuse potential of CNS active drugs are adequately characterized. Read more.
CE08—Toxicokinetics: A Tool That Enriches Study Design and Interpretation
Toxicokinetics (TK) is often rightly viewed as a means to measure exposure in animals to further understanding of adverse effects and to use in comparison to human exposure to gauge safety. Read more.
CE09—Clinical Pathology of Biotherapeutics
Educational Course Provided by STP
Biologic drug modalities are rapidly expanding in number and complexity, and this expansion has been accompanied by the observation of equally complex effects, both expected and unexpected, in nonclinical safety studies. Read more.
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