Nonclinical or Pre-Clinical studies are research studies that are conducted, typically on animals, before a permit for a clinical trial on humans can be obtained. Pre-clinical studies serve a vital role in the drug discovery and development processes. These studies can be used to identify lead compounds likely to possess favorable biopharmaceutic and pharmacokinetic properties in humans. In addition, they can facilitate transition of discovery to development, as well as decrease the need for expensive and time-consuming clinical studies.
Pre-clinical studies include a wide range of studies in a variety of systems to characterize biopharmaceutic and pharmacokinetic properties. Systems used include: in vivo animal models, isolated perfused liver, kidney, intestine, hind limb and heart, Caco-2 cell monolayer absorption model, animal and human liver microsomes. Studies include: bioavailability studies, pharmacokinetic studies, prediction of oral absorption in humans, determination of mechanisms of intestinal absorption, assessment of transport, distribution and elimination of compounds, validated models for cytochrome P450 enzymes, metabolism studies in human liver microsomes, assessment of potential for metabolic drug - drug interactions, analysis of drugs and metabolites in biological matrices, synthetic chemistry, in silico modeling.