医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Japan’s Agency for Medical Research and Development, AMED, Selects Certara’s Phoenix WinNonlin Software to Assess New Drug Candidates

2015年10月20日 PM09:00
このエントリーをはてなブックマークに追加


 

PRINCETON, N.J.

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20151020005164/en/

CONTACT

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief
Marketing Officer
or
Media Contact:
Rana
Healthcare Solutions
Lisa Osborne, 206-992-5245
lisa@ranahealth.com

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • 亚马逊与美国国家安全委员会携手开展业界首创合作项目,以解决美国常见的工伤问题
  • Aragen Announce Multi-Year Partnership With FMC Corporation, Aims at Accelerating Agro-Chemical Pipeline
  • 片肺換気中の高酸素血症介在疾患の罹患率にORiを指針とする酸素需要評価が及ぼす影響についての新研究
  • セルトリオン、抗COVID-19モノクローナル抗体治療剤「Regdanvimab(CT-P59)」の グローバル第3相臨床試験結果を発表
  • 沃特世推出SELECT SERIES MRT多反射飞行时间质谱平台,树立高分辨质谱性能新标杆