Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 321

Certara Celebrates 20th Anniversary of the Simcyp Simulator Consortium

Posted by fidest press agency su venerdì, 18 ottobre 2019

Certara, the global model-informed drug development and decision support leader, today announced that it is celebrating the 20th anniversary of its Simcyp® Consortium.The Simcyp Consortium was created as a collaborative research center to develop best practices and progress physiologically-based pharmacokinetic (PBPK) modeling and simulation, the science of studying drug handling by the body in computer-generated, virtual patients. Today, it counts 37 leading biopharmaceutical companies among its members and is a global authority on mechanistic PBPK modeling and simulation. Consortium members work together in a pre-competitive environment to progress model-informed drug development and create annual updates to Certara’s Simcyp Population-based Simulator.Mechanistic PBPK modeling and simulation has become a key technology in modern drug development. Simcyp Simulator modeling and simulation has resulted in the approval of more than 200 labels claims for more than 55 drugs without the need for clinical trials. The Simcyp Simulator has been adopted by all the leading regulatory agencies, including the US FDA, Europe’s EMA and Japan’s PMDA. The Simcyp Simulator is also employed to design optimal clinical trials, evaluate new drug formulations, and conduct virtual bioequivalence studies. In fact, earlier this year, the Simcyp Simulator was successfully used to demonstrate bioequivalence (BE) for the first US FDA approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.

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