Most people in our industry are familiar with the "Leaky Funnel" analogy that describes the model where we approach a large number of patients for inclusion in a study, but they leak out of the pipe at every juncture.

In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the U.S. economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.

The industry is facing new and emerging human toxicity concerns driven by worldwide consumer demand and changes to global living standards. From added microplastics and other substances classed as persistent, bioaccumulative and toxic - there is increasing scrutiny placed on the safety profile of your chemical.

Gases, by their very nature, are difficult to handle and analyze. They are, however, generally bound by the same regulatory requirements as solid or liquid substances, so the same endpoint data is required. Physicochemical endpoints such as partition coefficient are requested because they are used to estimate the bioaccumulation potential of a substance.

QSARs are valuable in silico tools that are used in combination with other NATs to answer regulatory questions about the likely toxicity of a new chemical. Many different QSAR systems exist, each with different strengths and weaknesses.

WC11 2021 -- Atherosclerosis (gradual narrowing of the arteries) is an inflammatory process involving a series of progressive cellular events, including monocyte adhesion to the luminal endothelial surface.

As part of a regulatory submission, we were approached by a European company who had been asked by regulators to supply additional operator exposure data. The substance under investigation contained both a pesticide and growth inhibitor, which is applied as a dust to stored potatoes.

An emerging biopharmaceutical company was considering development of a pharmacologic agent for treatment of patients with diabetic kidney disease (DKD). The company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria.

Ensuring your product is accepted by regulatory authorities, compliant with classification, labeling and safety standards, and up-to-date with the latest regulatory changes is a complex process that requires extensive insight on current guidelines.