Nonclinical studies

Nonclinical / Pre-Clinical Studies of Drug / Product Candidates

Pre-Clinical Studies should be done on animals, before the permit of clinical trial on humans could 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 favourable biopharmaceutic and pharmacokineticproperties in humans. In addition, they can facilitate transition through the discovery - development interface and 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, animaland human livermicrosomes. Studies include: bioavailabilitystudies, 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 biologicalmatrices, synthetic chemistry, in silico modeling.ru:Специалист по клиническим исследованиям

This article is licensed under the GNU Free Documentation License.
It uses material from the http://en.wikipedia.org/wiki/Nonclinical+studies Wikipedia article Nonclinical studies.