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Absorption, distribution, metabolism preclinical models

II. Product Summaries Simulations Plus develops simulation and predictive modeling software for in silico compound screening and for preclinical and clinical drug development in the area of Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET). The available applications include GastroPlus, ADMET Predictor, ADMET Modeler, DDDPlus, and MembranePlus. [Pg.229]

How can late-stage clinical attrition be reduced and yet still produce a safe and efficacious drug This is the number one question that every member of the biophar-maceutical industry is trying to answer. Reducing early-stage clinical attrition is a difficult task because animal models are not perfect predictors of efficacy and safety in humans [8], Many factors can confound the safety and efficacy predictions used to move a new chemical entity (NCE) into the clinic, among them absorption, distribution, metabolism, and excretion (ADME) properties and the mechanism of toxicity differences between the preclinical species and humans. [Pg.129]

Biotech and pharma companies outsource a number of different functions. In the discovery phase, the syntheses of building blocks, intermediates, and especially libraries are frequently outsourced, often to India or Eastern Europe. Offshoring of chemistry is frequent, that of biology less so. But ADME Absorption, Distribution, Metabolism, and Excretion) studies and animal models for preclinical development are now sometimes done in China, for example, at Shanghai s WuXi Pharmatech, whose customers currently include nearly all of big pharma and big biotech. ... [Pg.32]

Absolute bioavailability is a measure of the true extent of systemic absorption of an extravascularly administrated drug. Along with clearance and volume of distribution, absolute bioavailability is one of the important parameters to characterize PK. Low bioavailability of a drug can be caused by incomplete dissolution when administrated as a solid, inability to permeate membranes, and metabolic instability (first-pass metabolism). Despite the importance of absolute bioavailability, it is not routinely assessed due to the cost and toxicology requirements for such a study in a conventional study design, which requires an intravenous reference. Safety issues may arise due to solubility limitation and toxicity associated with Cmax effect. As a result, it is necessary to conduct a preclinical toxicological study with an IV formulation to ensure adequate human safety and potential problem. Bioavailability determined from animal models is not always predictive of that in human. [Pg.405]


See other pages where Absorption, distribution, metabolism preclinical models is mentioned: [Pg.4]    [Pg.426]    [Pg.435]    [Pg.246]    [Pg.6]    [Pg.259]    [Pg.346]    [Pg.70]    [Pg.25]   
See also in sourсe #XX -- [ Pg.171 , Pg.173 , Pg.175 ]




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