Certara, a global biosimulation technology-enabled drug development company, announced that Japan’s new Agency for Medical Research and Development (AMED) has selected the company'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 per cent 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 programme. 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 programme 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.