INVESTIGATING THE IMPACT OF ENZYME CORRELATIONS ON INTER-INDIVIDUAL VARIABILITY IN PHARMACOKINETICS AND DRUG-DRUG INTERACTIONS
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Tag: Drug-drug Interaction
Development of a Physiologically Based Pharmacokinetic Model of Buspirone and Its Active Metabolite 1-(2-Pyrimidinyl)-Piperazine to Estimate Drug-Drug Interaction and Food Effect
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Evaluation of Clinical DDI Potential of Methotrexate Using PBPK Modeling
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Formulations can have an impact on intestinal drug-drug interactions: A PBPK study using oxybutynin as a model drug
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Effect of Multiple Drugs Interacting with the hERG Channel – In Vitro Study
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Application of a physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) model for prediction of drug-drug interactions (DDIs) involving the JAK1/2 inhibitor Ruxolitinib in Caucasians and Japanese
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Application of a PBPK model for prediction of the DDI between Lorazepam and Probenecid.
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Do Rigorous Science, Benefit the Patients & Have Fun: Insights from Regulatory Expert Eva Berglund
Drug development is a global enterprise. One of the great things about working at Certara is the ability to learn from fantastic colleagues living around the world. My Swedish colleague, Dr. Eva Berglund, is a clinical pharmacologist who is now a Senior Director of Regulatory Strategy at Certara after spending a long and distinguished career […]
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Clinical Pharmacology Strategy, PBPK Modeling & SimulationPharmacology to Payer
Focus on Patient Centricity In traditional drug development, limited engagement—or engagement too late in the development program—between sponsors, regulators, and payers can result in unacceptable delays of patient access to life-saving medicines. While alternative approaches such as Adaptive Licensing, which includes staggered approval, managed entry, and progressive authorization have expedited the process, it addresses only […]
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Quantitative Systems Toxicology and Safety
A Pathway-based Approach to More Efficient Chemical Risk Assessment A major challenge in developing efficacious and safe drugs is the ability to understand and effectively predict adverse effects of xenobiotic substances on extremely complex biological systems early in the drug discovery process. An alarming fact is that thirty percent of adverse drug reactions (ADRs) cannot […]
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Drug Development and Clinical Pharmacology Strategy
Strategic Drug Development Involves Thinking Without Borders™ Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, will dramatically improve efficiency and reduce costs. Creating unquestionable value for our clients is our objective. To achieve these objectives, Certara employs a strategic and programmatic […]
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Simcyp PBPK Modeling and Simulation
Physiologically-based Pharmacokinetic (PBPK) Modeling: Getting Real Answers from Virtual Populations A recent FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners: “Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, […]
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