You are Invited to Participate in a Free Educational Webinar
Wednesday, February 12, 2020 at 11:00 AM EST
Hosted by American College of Toxicology
With support from Society of Toxicologic Pathology
and Safety Pharmacology Society
Speaker:
 |
Carol M. Galvis, PhD
Lead Pharmacologist
US Food and Drug Administration
|
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.
There is no fee but advance registration is required.
|
|