Japanese Regulatory Agency Licenses Certara’s Phoenix and Simcyp Software to Support Model-based Drug Development


Applied Clinical Trials

PRINCETON, NJ – Feb. 26, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today 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.

“Biosimulation is now consistently relied upon by regulatory agencies’ pharmacometrics teams in pre-clinical, clinical and post-approval drug development decisions,” said Certara CEO Edmundo Muniz, M.D., Ph.D. “Furthermore, a paper and survey from the International Consortium for Innovation and Quality in Pharmaceutical Development published by the American Association of Pharmaceutical Scientists last month stated that Phoenix was used by 100 percent of the 22 leading pharmaceutical companies surveyed, and 86 percent of them were using Simcyp. These percentages placed Certara’s offerings as the #1 and #2 ranked biosimulation solutions. We are proud to be working with PMDA, as it advances the use of these innovative modeling approaches from regulatory science to regulatory approval.”

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.

Certara’s Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for the prediction of drug-drug interactions, assisting in dose selection, and informing clinical decisions related to product labeling. Simcyp whole body simulation methodology can predict the pharmacokinetics of drug compounds and proteins based on in vitro data. The simulator includes a unique set of genetic, physiological and epidemiological databases that facilitate the simulation of virtual populations from around the globe. 

In addition to PMDA, all leading Japanese pharmaceutical companies have integrated both the Phoenix and Simcyp biosimulation solutions into their drug development workflow.

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