Using Short-term In Life Transcriptomic Studies to More Effectively Assess Dose Responses and Modes of Action

Melvin Andersen Blog

In the past, dose responses results from in life toxicology studies were used to estimate no observed effect levels (NOELs) and more recently benchmark doses (BMDs). These observational studies of apical endpoints were frequently followed up by mechanistic studies both in intact animals and in in vitro models to determine modes of action (MOAs) and lend support to using either linear or threshold-based low dose extrapolations.  Over the past two decades, gene expression analysis …

Guidelines for assessing Pharmacokinetic Bias in Epidemiology

Melvin Andersen Blog

Melvin E. Andersen Biomarkers of exposure can be measured at lower and lower levels due to advances in analytical chemistry. Using these highly sensitive methods, some epidemiology studies report associations between plasma and urinary biomarkers and health outcomes at biomarker levels much below those associated with effects in animal studies. In some cases, these associations may arise from pharmacokinetic (PK) bias, i.e., a situation where a confounding …