PRINCETON, NJ – Oct. 19, 2016 – Certara announces that the Office of Generic Drugs (OGD), US Food and Drug Administration (FDA) has awarded it a multi-year research grant to create and validate a physiologically-based pharmacokinetic (PBPK) modeling and simulation framework that complements existing models within the Simcyp Population-based Simulator.
FDA is planning to introduce new eCTD validation criteria it will use to enforce requirements for clinical and non-clinical study data submitted electronically. The study data validation errors (2 High, 2 Medium) will apply to the following eCTD sections – 4.2 Study Reports and 5.3 Clinical study reports and related information. FDA is asking sponsors … Continued
On September 14, Dr. Nathan Teuscher presented an informative webinar focused on new features and enhancements in Phoenix® 7.0, which was released on August 10. This blog post summarizes the topics discussed during the presentation. Nathan began his presentation with an overview of new features in Phoenix 7.0 including: A new graphics engine for high … Continued
PRINCETON, NJ – Oct. 13, 2016 – Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that Peking Union Medical College (PUMC) Hospital in Beijing, China, and Keio University in Tokyo, Japan have become Phoenix Centers of Excellence.
Modeling and simulation in drug development could change the commercial and regulatory landscape forever… and can deliver significant business, scientific and clinical value to companies.
It may be 2016, but we just held the 17th annual Simcyp Consortium meeting in Sheffield, UK. This year’s gathering had >120 attendees with representatives from all but one of the 34 consortium member companies joining. The opening session reviewed the progress made by the Simcyp staff toward the field of regulatory science, physiologically-based pharmacokinetic … Continued
PRINCETON, NJ – Oct. 6, 2016 – Certara announces that Kelley Kendle, president of Synchrogenix, its medical and regulatory writing consultancy, has been named a Delaware Business Times (DBT) 40 honoree. This is an annual listing of Delaware’s influential achievers and innovators under the age of 40.
Metritis is a frequent problem in postpartum dairy cows. Intrauterine therapy with the antimicrobial oxytetracycline (OTC) is often used, although this therapy has not been shown to be superior to systemic therapy. The objectives of this study were to (1) determine the plasma and milk concentrations of OTC following intrauterine infusion in postpartum dairy cows … Continued
The aim of this study was to derive quantitative abundance values for key hepatic transporters suitable for in vitro-in vivo extrapolation (IVIVE) within a physiologically-based pharmacokinetic modeling framework. A meta-analysis was performed whereby abundance measurements, sample preparation method and donor demography were collated from literature. In order to define values for a healthy Caucasian population, … Continued
