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ChemoCentryx Shares Rise 10% After Filing NDA Amendment for Avacopan
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ChemoCentryx Shares Rise 10% After Filing NDA Amendment for Avacopan
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AM-Pharma B V : AM-Pharma Enrolls First Patient in Japan for Ongoing Phase III SA-AKI Pivotal REVIVAL Trial
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AM-Pharma Enrolls First Patient in Japan for Ongoing Phase III SA-AKI Pivotal REVIVAL Trial
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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