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Preclinical research phase

Research (on medicines). Numerous definitions of research are used both in the literature and among scientists. In the broadest sense, research in the pharmaceutical industry includes all processes of medicine discovery, preclinical and clinical evaluation, and technical development. In a more restricted sense, research concentrates on the preclinical discovery phase, where the basic characteristics of a new medicine are determined. Once a decision is reached to study the medicine in humans to evaluate its therapeutic potential, the compound passes from the research to the development phase. [Pg.994]

Alzheimer s Disease The vaccine being tested contains a small protein called jS-amyloid (AjS). This protein forms abnormal deposits, or plaques, in the brains of people with Alzheimer s disease. Researchers believe that Kji deposition causes loss of mental function by killing the brain neurons. The strategy of Aji vaccination is to stimulate the immune system to clean up plaques and prevent further A deposits. Although preclinical and Phase I studies showed the potential of the vaccine, the Phase II clinical trial was halted because 15 of 360 patients developed severe brain inflammation. Further studies showed that the A did generate the desired... [Pg.103]

The principal issue in the drug discovery process is the high failure rate in the clinical trials, mainly due to liabilities related to poor pharmacokinetics (PK), poor efficacy, and high toxicity. The earlier lead optimization (LO) phase then represents a crucial step in the drug discovery process, since it involves the preparation and the selection of suitable drug candidates. In view of the increasing need for speed in the preclinical research and development, the determination of activity and selectivity is performed simultaneously with the evaluation of pharmacokinetic and toxicity properties. This multiparametric approach allows the early selection of the compounds with the best overall balanced druglike profile [1]. [Pg.355]

In addition, there is the added complexity of finding the optimal dose of neuroprotective and hypothermia treatment that will result in the optimal degree of neural protection. Because of the possibility of treatment interactions, significant preclinical testing will be necessary to identify the most clinically feasible and neurologically potent therapeutic regimen. This may be quite difficult, as the translation of preclinical research to human subjects is inexact. Added testing in phase I (safety) and phase II (dose escalation) human trials will be necessary, with a special emphasis on possible adverse interactions between the treatments. [Pg.96]

The preclinical research and development starts after the discovery and the isolation of a promising compound in the laboratory. The biological activity and safety is extensively studied in the laboratory and tested on animals. This phase is usually completed in 6 years. [Pg.366]

Once phase I is complete, the humans become the first-choice test species, under all but the most specialized of circumstances (e.g. effects on reproduction). In this context, phase I serves as the interface between preclinical research and clinical development, and the validity of the predictions from animals to humans involved is of paramount importance. [Pg.98]

Pharmacokinetics and pharmacodynamics have always had an important role in drug delivery research. Investigating pharmacokinetic and pharmacodynamic issues during lead optimization is a critical part of the drug discovery and development process. The decision to move forward with a particular compound often depends on pharmacokinetic (PK) and pharmacodynamic (PD) evaluations at several stages in drug development, from early preclinical through Phase I, II, and III studies. It is... [Pg.73]

There is only sketchy information on trends in the allocation of new-product R D between discovery research and clinical trials. DiMasi and colleagues asked 12 U.S. companies to estimate R D expenditures for clinical and preclinical research on self-originated NCEs for the period 1970-86 ( 107). Over the entire period, 66.1 percent of research on self-originated drugs was reported as devoted to the preclinical phase. No clear trends were evident in the ratio over time (106), suggesting the allocation of R D dollars has remained stable over time. [Pg.45]

At UCLA, colleagues at the Alzheimer s Disease Preclinical Research Lab have been studying fatty acids and other nutrients for years, looking for doorways to potential cures for Alzheimer s disease. In one phase of research, they fed mice a diet rich in DHA and found that the fatty acid protected against protein loss in the brain synapses and prevented cognitive deficits. They noted 40 to 50 percent fewer... [Pg.177]

More recently, the bottleneck of drug research has shifted from hit-and-lead discovery to lead optimization, and more specifically to PK lead optimization. Some major reasons are (i) the imperative to reduce as much as feasible the extremely costly rate of attrition prevailing in preclinical and clinical phases, and (ii) more stringent concerns for safety. The testing of ADME properties is now done much earlier, i.e. before a decision is taken to evaluate a compound in the clinic. [Pg.497]

Preclinical studies Animal studies that support Phase I safety and tolerance studies and must comply with Good Laboratory Practice (GLP). Other preclinical studies are done in discovery research laboratories to support drug efficiency claims. [Pg.772]


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