In the development phase of a new drug product, researchers must examine the activity of a compound in relevant model systems that can mimic human physiology to assess its safety and toxicity. Drug metabolism and pharmacokinetics testing, such as absorption, distribution, metabolism, and excretion (ADME) and toxicology studies, are a critical step in this process.
ADME and toxicology studies are conducted during the preclinical stage of drug development process before filing an Investigational New Drug (IND) application, prior to any clinical trial. Many early candidates are prevented from reaching the market due to inappropriate ADME properties and drug-induced toxicity.
Tools that help to predict the ADME responses early in development present an advantage to researchers as they mitigate the risk of late-stage failure. For example, in vitro metabolite profiling, structural activity elucidation, and drug-drug interaction (DDI) studies are critical for IND and New Drug Application (NDA) submissions during preclinical development. Selecting the most appropriate in vitro assays and animal models is also imperative.
We provide the most comprehensive and innovative line of instrumentation, software, reagents, and consumables, as well as state-of-the-art informatics and services that enable our customers to meet compliance requirements throughout the ADME/tox studies.