As the various online repositories of toxicological information accrue and high-throughput screening technology creates billions of data points as a matter of course, the problem of data analytics and interpretation looms large for toxicologists used to traditional toxicity studies.
The presenters during the 2018 “Reducing the Uncertainty of Read-Across Predictions by New Approach Methodologies: Application in Regulatory Human Risk Assessments” Session provided good reasons to abandon old risk assessment habits and embrace new approach methodologies (NAM).
The successful and well-attended “Nonclinical to Clinical Translation of Antibody-Drug Conjugates” Workshop Session at the 2018 Annual Meeting and ToxExpo highlighted the challenges in nonclinical to clinical translatability of ADCs and regulatory considerations based on ICH S9.
This Scientific Session during the 2018 Annual Meeting and ToxExpo provided a comprehensive overview of the various tools available to assess the potential of drug candidates to induce adverse cardiovascular events.
A systematic review (SR) is a secondary research process (research on research) and is gaining popularity in regulatory space lately. This 2018 session focused on the systematic review process and evidence-based methodologies (Big “S” and Big “R”) in toxicology regulator decision making.