As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from … Continued
In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook introduced the Cardiac Safety Simulator (CSS) platform and explained how they developed a QSTS model for citalopram to serve as a “virtual twin” and help predict the likely occurrence of cardiotoxic events in real patients under different clinical conditions.
PRINCETON, NJ – 6월 14, 2018 – Certara was privileged to participate as a key member of the Medicines Development for Global Health development team to achieve FDA approval of moxidectin.
In this webinar, Noreen Muscat from QACV Consulting discussed common pitfalls in validation and how to avoid them, and Allan Michaels, Sr. Project Manager of Phoenix Technology Services, shared how the latest Validation Suite for Phoenix WinNonlin expedites validation and provides robust reporting.
As the gold standard for PK/PD software, our upcoming Phoenix 8.1 release delivers new capabilities to automate processes, reduce errors, and save you time. Dr. Nathan Teuscher, VP of Pharmacometric Consulting, Venkateswari Muthukrishnan, Phoenix WinNonlin Product Manager, and Ana Henry, Executive Director of Training, shared our latest innovations in WinNonlin and NLME and conducted a live demo.
PRINCETON, NJ – 6월 5, 2018 – Certara today announced the launch of Phoenix 8.1.
Apixaban is an orally available, direct, selective inhibitor of the coagulation factor Xa that reversibly binds to the active site of FXa, and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. Apixaban is approved in multiple regions for VTEtx, based on the results of a Phase 3 study (AMPLIFY [1]). … Continued
