Both epidemiology and laboratory data can contribute to estimates of risks to humans of exposure to low doses of carcinogens. The sum of all these contributions does not permit us to make these ...

In Vitro–In Vivo Extrapolation (IVIVE) is a method that allows researchers to predict the rate at which substances are metabolized within the human liver and are then eliminated from the body. IVIVE ...

Pfizer released full tafamidis data demonstrating a 30% reduction (29.5% vs 42.9%) in the risk of all-cause mortality and a 32% reduction in CV-related hospitalizations. The market has ...

The Food and Drug Administration issued a final guidance on Monday for how and when existing clinical data should be used to support pediatric medical device indications and labeling. The guidance ...