Watch this webinar to learn how to use simulation to anticipate risks and preview the range of possible trial results before millions of R&D dollars are spent exposing subjects to experimental therapies.
Watch this webinar to learn how to use in vitro and in vivo models to find direct time scaling factors and confirm the similarity of the in vitro and in vivo release mechanisms.
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and … Continued
PRINCETON, NJ – February 21, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the launch of version 19.1 of its flagship scientific informatics platform D360.
Synchrogenix was well represented at DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Forum held earlier this month. One of the reasons RSIDM is such a valuable meeting for Regulatory Operations professionals is because it is so well attended by U.S. FDA staff members who participate both as speakers and fellow attendees. We particularly look … Continued
The astronomical cost of conducting clinical drug trials means that a suboptimal trial design adds significant risk to a drug program. Clinical trial simulation allows drug developers to test different trial designs in silico before exposing patients to an experimental drug. In this blog post, I’ll explain how Certara’s Trial Simulator balances ease-of-use with robust … Continued
PRINCETON, NJ – February 7, 2019 – Certara has recently published four peer-reviewed MIPD papers; its progress is generating strong interest from industry, health care professionals and regulators.
This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is an industrial and regulatory necessity in modern drug development.
PRINCETON, NJ – February 4, 2019 – Certara today announced that Justin Edge has joined Certara as President of Synchrogenix, the company’s regulatory science division.
