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Pharmacokinetics Simulation
Pharmacokinetics simulation is a simulation method used in determining the safety levels of a drug during its development. Purpose Pharmacokinetics simulation gives an insight to drug efficacy and safety before exposure of individuals to the new drug that might help to improve the design of a clinical trial. Pharmacokinetics simulations help in addition in therapy planning, to stay within the therapeutic range under various physiological and pathophysiological conditions, e.g., chronic kidney disease. Simulators Simcyp Simulator and GastroPlus (from Simulations Plus Simulations Plus, Inc. develops absorption, distribution, metabolism, excretion, and toxicity ( ADMET) modeling and simulation software for the pharmaceutical and biotechnology, industrial chemicals, cosmetics, food ingredients, and herbicide indu ...) are simulators that take account for individual variabilities. PharmaCalc v02 and PharmaCalcCL allow to simulate individual plasma-concentration time curves based on ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process – from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials – to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. Th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Chronic Kidney Disease
Chronic kidney disease (CKD) is a type of kidney disease in which a gradual loss of kidney function occurs over a period of months to years. Initially generally no symptoms are seen, but later symptoms may include leg swelling, feeling tired, vomiting, loss of appetite, and confusion. Complications can relate to hormonal dysfunction of the kidneys and include (in chronological order) high blood pressure (often related to activation of the renin–angiotensin system system), bone disease, and anemia. Additionally CKD patients have markedly increased cardiovascular complications with increased risks of death and hospitalization. Causes of chronic kidney disease include diabetes, high blood pressure, glomerulonephritis, and polycystic kidney disease. Risk factors include a family history of chronic kidney disease. Diagnosis is by blood tests to measure the estimated glomerular filtration rate (eGFR), and a urine test to measure albumin. Ultrasound or kidney biopsy may be performe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Simcyp Simulator
Simcyp Limited is a research-based company which provides modelling and simulation software to the pharmaceutical industry for use during drug development. Simcyp is based in Sheffield, UK. Simcyp’s Simulators allow '' in silico'' prediction of drug absorption, distribution, metabolism and excretion ( ADME) and potential drug-drug interactions. Research and development Simcyp’s R&D activities focus on the development of algorithms along with population and drug databases for modelling and simulation (M&S) of the absorption and disposition of drugs in patients and specific subgroups of patients across different age ranges. The Simcyp models use experimental data generated routinely during pre-clinical drug discovery and development from ''in vitro'' enzyme and cellular systems, as well as any relevant physico-chemical attributes of the drug and dosage forms. Some details of the scientific background to Simcyp approaches can be found in recent publications. Background Simcyp or ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Simulations Plus
Simulations Plus, Inc. develops absorption, distribution, metabolism, excretion, and toxicity ( ADMET) modeling and simulation software for the pharmaceutical and biotechnology, industrial chemicals, cosmetics, food ingredients, and herbicide industries. In September 2014, the company acquired Cognigen Corporation, a provider of clinical trial data analysis and consulting services. ReferencesSimulations Plus, Inc. - San Fernando Valley Business Journal - December 29, 2010 * [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Simulation
A simulation is the imitation of the operation of a real-world process or system over time. Simulations require the use of Conceptual model, models; the model represents the key characteristics or behaviors of the selected system or process, whereas the simulation represents the evolution of the model over time. Often, computers are used to execute the computer simulation, simulation. Simulation is used in many contexts, such as simulation of technology for performance tuning or optimizing, safety engineering, testing, training, education, and video games. Simulation is also used with scientific modelling of natural systems or human systems to gain insight into their functioning, as in economics. Simulation can be used to show the eventual real effects of alternative conditions and courses of action. Simulation is also used when the real system cannot be engaged, because it may not be accessible, or it may be dangerous or unacceptable to engage, or it is being designed bu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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