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Efforts Underway to Mine Big Data for Better Safety Assessments

Safety assessments are important. The process of evaluating human, animal, and environmental toxicity data is crucial for regulators, researchers, and companies that sell chemicals or biologics. The speakers for the 2018 Annual Meeting and ToxExpo Symposium Session “Application of Data from New...

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Trying to Improve Predictions of Adverse Cardiovascular Event Potential Early in Drug Development

The “Cardiovascular Effects Are Still Causing Late Attrition of Novel Therapeutics: Developing Solutions to Detect and Avoid Cardiovascular Toxicity in the Clinic” Scientific Session during the 2018 Annual Meeting and ToxExpo provided a comprehensive overview of the various tools available to...

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Antibody-Drug Conjugates: Are “Smart Bombs” Smart Enough?

The limited number of therapeutic options for several oncological and hematological diseases and recent advances in antibody engineering and conjugation technologies have made antibody-drug conjugates (ADCs) an emerging option for cancer treatment. ADCs have a complex structure comprised of a...

Blog Entry
Read-Across Uncertainties in Risk Assessments: NAM to the Rescue!

For those of us in the risk assessment arena, deriving health reference values with a classic animal-based approach is part skill and part habit, honed by years of scouring in vivo studies to identify critical health effect endpoints, executing dosimetric conversions to deduce human equivalent...

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Using Chemical Grouping for More Effective Chemical Selection and Assessment

Chemical grouping is an important tool that helps researchers and regulators sort through the universe of chemicals to identify the safe, the unsafe, and the useful. The “Chemical Grouping for 21st-Century Toxicology, Risk Assessment, and Decision Making” session during the 2018 Annual Meeting...

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Use of Systematic Review to Support Regulatory Decision-Making

A systematic review (SR) is a secondary research process (research on research) and is gaining popularity in regulatory space lately. The 2018 SOT Annual Meeting and ToxExpo Informational Session “Moving Beyond Theory to the Use of Systematic Review to Support Regulatory Decision Making for...

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Bird's-Eye View of Accepting Uncertainty in the 21st Century

The topic of uncertainty could easily be one of the most controversial yet relevant conversations in the field of toxicology currently. The 2018 Continuing Education course entitled “Uncertainty Characterization in 21st-Century Toxicology: Current Practice and Practical Methods Supporting...

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Bridging Exposure Science into Future Human Health Risk Assessment

Human health risk assessment has four critical components: hazard identification, exposure assessment, dose-response assessment, and risk characterization. However, human health risk assessment is traditionally hazard driven because the exposure data is limited at the initial stage and usually...

Blog Entry
Biotherapeutic Development: Lessons Learned and Future Considerations to Solve the Conundrum

Recent years have seen an increasing surge in the development of novel biotherapeutics. Preclinical safety evaluation plays a crucial role in drug development and the highly diverse modalities and complexity of biotherapeutics poses several development challenges, such as identifying relevant...