Strategic Consulting and Advisory Services
Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Software Portfolio: 'End-to-end' Modeling
Certara biosimulation (model based drug development and informatics) software portfolio is the most wide-ranging in the industry. Certara technology is relied upon by over 1,500 biopharm companies and academic institutions for drug research and development.
Certara's Programmatic Consulting Approach Delivers Unquestionable Value to Sponsor Companies
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
Leading Edge Science: Resource Library
Check out the latest brochures, case studies, white papers, webinars, and more! Search by keywords and/or filter results.
Japanese Medical Research and Development Agency Selects Phoenix WinNonlin Software
October 20, 2015
PRINCETON, NJ – Oct. 20, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that Japan’s new Agency for Medical Research and Development (AMED) has selected Certara’s Phoenix® WinNonlin® software for pharmacokinetic/pharmacodynamic (PK/PD) modeling and non-compartmental analysis of new drug candidates. AMED was launched on April 1, 2015 and fulfills a similar role to the National Institutes of Health in the United States.
“Considered the gold standard for PK/PD and non-compartmental analysis, Phoenix WinNonlin is being used by more than 6,500 researchers at more than 1,500 biopharm companies, academic institutions and global regulatory agencies,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “In fact, Phoenix WinNonlin is relied upon by 100 percent of leading pharma companies, according to survey results published in the January 2015 IQ Consortia report on preclinical PK/PD modeling. We are delighted that AMED chose to start working with Certara right away as the Agency expands its drug development analysis capabilities.”
Prime Minister Shinzo Abe is counting on AMED to move drugs from the bench into the clinic and onto the market. AMED is expected to employ Phoenix WinNonlin to create PK profiles, and assess bioavailability for new drug candidates in its preclinical program. These data will help AMED’s domestic and international biopharmaceutical partners to identify which molecules hold the most therapeutic potential and should be progressed into clinical trials. AMED is currently testing about 200,000 samples provided by 10 biopharmaceutical companies. However, it plans to open the program to additional biopharmaceutical partners shortly. Its initial focus is on the development of drugs for cancer and infectious diseases. AMED will flag promising molecules for its partners and request that they develop them further.
Phoenix WinNonlin is the trusted, long-time industry standard software tool for PK/PD modeling, non-compartmental and compartmental analysis. It is easily validated, delivering accurate, reproducible and traceable results. WinNonlin has powerful graphics, an extensive model library, and its results can readily be shared in a single file with collaborators. It can also perform a bioequivalence analysis, or create a simulation of multiple doses, from single-dose data.
About Certara
Certara is a global biosimulation technology-enabled drug development company. Its customers include hundreds of
biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which
span the discovery, preclinical and clinical stages of drug development, enable superior drug development and
regulatory decision-making through biosimulation, thus increasing R&D productivity and commercial value. For more
information, visit www.certara.com.
Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com
Back to News