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Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Biosimulation Software for Evaluating Regulatory Submissions The PMDA enters 8th consecutive year of using Certara’s biosimulation software June 23, 2021 19:00 ET | Source: Certara Certara Princeton, New Jersey, UNITED STATES PRINCETON, N.J., June 23, 2021 (GLOBE NEWSWIRE) Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ and Phoenix™ biosimulation software. The PMDA has been using Certara’s biosimulation software since 2014. The Simcyp Physiologically-Based Pharmacokinetic (PBPK) Simulator is used in drug development to determine first-in-human dose, design more efficient and effective clinical studies, and predict drug-drug interactions using virtual populations. The Phoenix Pharmacokinetic and Pharmac

United statesDavid deuchlerWilliam feeheryCertara simcypJapan ministry of healthJapanese pharmaceuticalsGilmartin groupDevices agencyMedical devices agencySimcyp physiologically based pharmacokineticPhoenix pharmacokineticDrug exposureAnalysis reports involving physiologicallyPharmacokinetic modelsModel informed drug developmentRelations contact