Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]
Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.
Modeling and simulation can help guide critical decisions around dosing and toxicity, efficacy and mechanism of action, clinical trial design and cohort selection, and commercial probability of success as compared with existing therapies or others in development.
PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.
Certara’s Trial Simulatior Engine is a tool with a command-line interface that can be used to determine the effects of variability in drug and subject characteristics on the likelihood of trial success. Users can conduct sequential and parallel subject simulations for real-world trial simulations.
QSP models are inherently complex and difficult to use in a clinical setting. Rigorous model reduction methods alleviate the complexity, bolster the use of QSP models for valuable gains, resulting in the extraction of a practical useable model from biological understandings.
On October 25, 2017, the FDA published two new guidance documents on drug-drug interactions (DDI). These guidance documents replace the February 2012 guidance, “Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” According to the FDA, these new guidances reflect the agency’s current thinking and greater learnings on DDI and provides a […]
PRINCETON, NJ – Nov. 7, 2017 – Certara today announced that it will be participating in 12 sessions at the 2017 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. This conference will be held from November 12–15 at the San Diego Convention Center in San Diego, CA.
Phoenix® WinNonlin® uses Phoenix Modeling Language (PML) to encode pharmacokinetic (PK) and pharmacodynamic (PD) models. Although most models can be built using the Phoenix graphical user interface (GUI), some models require custom coding with PML. During the latter part of 2016, Certara’s support team, led by Dr. Bernd Wendt, Director of Training and Support, introduced […]