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Applied Clinical Trials
Japanese Regulatory Agency Licenses Certara’s Biosimulation Software
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Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator.
Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator. PMDA joins FDA and several other global regulatory agencies in increasing its reliance on biosimulation for investigational new drug and new drug approval reviews.
PMDA is using PPK (population pharmacokinetic), PK/PD (pharmacokinetic/pharmacodynamic), and other modeling and biosimulation approaches for dosage, dose regimen and dose adjustment for special populations, including pediatrics. In addition, PKS Online will provide the technical infrastructure necessary to securely store and manage PK and PD study data, and the associated pharmacometric analyses, in a regulatory-compliant environment.
Read the full release here.
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