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Tag: Simcyp

The Next Horizons in Predicting Drug-drug Interactions

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Physiologically-based pharmacokinetic (PBPK) modeling has arrived in prime time. This quantitative mechanistic framework, combining physiology with drug information and clinical trial design, has become an integral part of drug discovery and development. PBPK has also gained currency within industry and regulatory agencies. Its applications are numerous, including simulation of pre-clinical, healthy volunteer and special population … Continued

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

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Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s … Continued

Japan Workshop August 2016

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This event runs from 1st – 5th August 2016 in Tokyo, Japan By participating in this workshop, you can learn how to predict the following items. Drug metabolic clearance (CL) Drug interactions was through the metabolism · (DDIs) The first pass in the gastrointestinal tract And absorption after oral administration (including the effects of diet … Continued

Certara Launches Version 15 of Its Simcyp Population-based Simulator

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PRINCETON, NJ – Dec. 8, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced the release of version 15 of its Simcyp® Population-based Simulator. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically-based pharmacokinetic (PBPK) modeling and simulation platform for determining first-in-human dose selection, predicting drug-drug interactions (DDIs), understanding drug disposition … Continued

Modeling the Influence of Ethnicity on Drug Disposition

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Ever noticed how people from different ethnic backgrounds respond differently to drugs? For example, you may enjoy having a few drinks with friends on the weekend.  When your friends with Eastern Asian heritage drink alcohol, it’s not uncommon for their faces to turn red. This happens because many East Asians possess an enzyme deficiency for … Continued

Assessing the Impact of Liver or Kidney Disease on Pharmacokinetics

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Impaired hepatic or renal function can have a major impact on pharmacokinetics. There is a high risk of adverse events in patients with these conditions. Major pharmaceutical companies and drug regulatory agencies use physiologically-based pharmacokinetic (PBPK) modeling in virtual populations to investigate the impact of hepatic or renal impairment on drug exposure as a supplement to … Continued

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

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Bioavailability of orally administered drugs can be influenced by a number of factors including release from the formulation, dissolution, stability in the gastrointestinal (GI) environment, permeability through the gut wall and first-pass gut wall and hepatic metabolism. Although there are various enzymes in the gut wall which may contribute to gut first pass metabolism, Cytochrome … Continued

Certara Scientists Participate in 9 Presentations at the North American ISSX Meeting

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Diverse agenda underscores the widespread adoption of PBPK approaches throughout the drug development process PRINCETON, NJ – Oct. 19, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its scientists are presenting 9 seminars and poster sessions at the twentieth International Society for the Study of Xenobiotics (ISSX). This annual ISSX … Continued

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