Month: December 2016
Was it just me or did 2016 just seem to fly by? Reflecting on the events of the past year, I stumbled across this quote which seemed appropriate: There are years that ask questions and years that answer. [Zora Neale Hurston, Their Eyes Were Watching God] Our mission at Certara is helping our clients optimize … Continued
Certara scientists helped Roche apply an integrated clinical pharmacology program to support the development and global approval of Tamiflu for infants.
The Phoenix IVIVC Toolkit provides enhanced tools for in vitro-in vivo correlation studies used by formulation and pharmaceutical scientists to improve the success of BE studies. The IVIVC Toolkit approach requires less assumptions, as compared to other methods, and helps the user define the correlation observed from real in vivo profiles as compared to the dissolution profiles.
During the past few years, model-informed drug development (MIDD) has evolved from a research nicety to a regulatory necessity. Certara is committed to changing the game in drug development by fully leveraging MIDD across the development cycle.
In our increasingly noise-filled world, sometimes, the most powerful insights come from listening. As the head of support at Certara, I get excited about listening to our clients’ pharmacokinetic/pharmacodynamic (PK/PD) modeling dilemmas and helping them solve them. And through listening to our users who call our support hotline, attend our training courses, or participate in … Continued
PRINCETON, NJ – Dec. 6, 2016 – Certara today announced that it is establishing a new Quantitative Systems Toxicology (QST) Initiative. That initiative, which will be managed by the company’s Simcyp division, leverages its Quantitative Systems Pharmacology (QSP) expertise.
PRINCETON, NJ – Dec 7, 2016 – Certara today announced the launch of its Phoenix WinNonlin Validation Suite 7.0. This application simplifies and expedites the validation process for Phoenix WinNonlin software, which is used extensively for drug regulatory submissions.
According to the FDA’s Guidance for Industry on Drug-drug interactions (DDIs), assessment of a new drug’s DDI liability has three major objectives: determining whether any interactions necessitate dosing adjustment, informing the extent of therapeutic monitoring that may be required and identifying any potential contraindications to concomitant use when lesser measures cannot mitigate risk Physiologically-based pharmacokinetic … Continued