= Members Only
ACT sponsors quarterly webinars on current topics in toxicology, including primarily drug and chemical safety assessments. Presenters are experts in their field, with backgrounds in government, industry or academia. The goal of the webinar series is to provide accessible education on topics in toxicology to ACT members and, more broadly, members of the toxicology community worldwide. ACT Webinars are reaching thousands, with collaborations spanning the globe while increasing individual and corporate ACT membership and participation. The ACT Signature Webinars are approximately 90 minutes, which includes questions and answers.
Safety Assessment of Metabolites in Drug Development: Current Perspective
Hosted by American College of Toxicology
Supported by Society of Toxicologic Pathology and Safety Pharmacology Society
Moderated by Kara Polhamus and Sam Tadepalli
Date and Time: February 12, 2020 at 11:00 am (EST)
Description: This webinar will provide an overview of safety assessment of metabolites in drug development. The speaker will discuss relevant guidance documents and will describe important considerations for the safety assessment of drug metabolites, including type of studies required and timing of submission to regulatory Agencies. This topic has evolved over the last few years and the speaker will incorporate FDA recent case studies that will provide participants insight into the regulatory decision-making process regarding this topic. Examples will include unique human metabolites, disproportionate human metabolites, metabolites that are acyl glucuronides, and examples of safety assessment of drug metabolites for severe, debilitating, and life-threatening (SDLT) conditions.
Speaker: Carol M. Galvis, PhD
There is no fee but advanced registration is required.