Rostami is recognized for his scientific leadership, original thinking, and commitment to knowledge sharing with his colleagues and students PRINCETON, NJ – Jan. 29, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it has promoted Amin Rostami, Pharm.D., Ph.D. to senior vice president (SVP) of R&D … Continued
Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug. To satisfy regulatory expectations, these computer systems should be validated. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data … Continued
Phoenix® WinNonlin® Validation Suite™ 4.0 can help ensure compliance, reduce total cost of ownership and improve work efficiency PRINCETON, NJ – Jan. 27, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced the launch of Phoenix WinNonlin Validation Suite 4.0 for automatic validation of the recently released Phoenix … Continued
New European and U.S. clinical trial data transparency initiatives—such as EMA Policy 70, which goes into effect this month—are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, I’ll discuss the implications of these data transparency initiatives and present how Synchrogenix, powered by ClinGenuity and a Certara company, is addressing this emerging … Continued
Nichols brings more than 25 years of technology leadership in clinical informatics and advanced analytics to the company PRINCETON, NJ – Jan. 20, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it has appointed Gavin Nichols to the newly-created position of president of technology. Mr. Nichols … Continued
As a scientist at Certara and proud Dad to my three kids, pediatric drug development is a topic that is near to my heart. Clearly, children are not just “small adults.” They require special consideration for their distinct physiology during drug development. Likewise, for ethical reasons, it is important to minimize children’s exposure to experimental … Continued
Deal provides Synchrogenix with proprietary technology, expert staff, and new capabilities to become the dominant player in life science regulatory and medical writing PRINCETON, NJ – Jan. 6, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, the … Continued
Although advantages of physiologically based pharmacokinetic models (PBPK) are now well established, PBPK models that are linked to pharmacodynamic (PD) models to predict pharmacokinetics (PK), PD, and efficacy of monoclonal antibodies (mAbs) in humans are uncommon. The aim of this study was to develop a PD model that could be linked to a physiologically based mechanistic FcRn model to predict PK, PD, and efficacy of efalizumab. The mechanistic FcRn model for mAbs with target-mediated drug disposition within … Continued
The objective of the present study was to evaluate mechanistic pharmacokinetic models describing active renal secretion and reabsorption over a range of Michaelis-Menten parameter estimates and doses. Plasma concentration and urinary excretion profiles were simulated and renal clearance (CLr) was calculated for two pharmacokinetic models describing active renal reabsorption (R1/R2), two models describing active secretion (S1/S2), and a model containing both processes. A range of doses (1-1,000 mg/kg) was evaluated, and Vmax and Km parameter estimates were varied over a … Continued
