HESI's Associate Directory, Michelle Embry, will be giving a talk December 8th, 2021 from 3-4pm EST titled "Opportunities and Challenges Related to Saturation of Toxicokinetic (TK) Processes: Implications for Risk Assessment" as part of a webinar jointly sponsored by the Risk Assessment Specialty Section (RASS) and the Biological Modeling Specialty Section (BMSS) of the Society of Toxicology (SOT).
Next generation risk assessment increasingly demands reduction of animal use. However, in many contexts, fit-for-purpose animal-based toxicity testing, such as long-term repeat-dose testing, is expected to remain in the foreseeable future. Recognizing the value in conducting these animal studies, it is crucially important to optimize the study design of long-term, repeat-dose studies by leveraging complementary data to ensure that these studies provide dose-response information that is relevant to human exposures. Overall, study design is best optimized by collectively assessing the available body of knowledge to achieve a science-based recommendation on the uncertainties and knowledge gaps. Many in vitro, in silico, and targeted in vivo approaches can be integrated to help inform animal study design, including dose selection and measurement of additional endpoints without increasing animal use. Traditionally, top dose selection for repeated dose studies has focused on apical endpoints, limit dose, or maximum tolerated dose. However, study design should consider instances where dose-response relationship becomes difficult to interpret due to systemic exposures being significantly disproportional to external doses, which can arise due to saturation or limitation of toxicokinetic (TK) process(es), such as absorption or metabolism.
Webinar Details: https://www.toxicology.org/groups/ss/RASS/events.asp