Year: 2016
Impact of Target-mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Mechanistic Dissolution, Supersaturation and Precipitation Models to Simulate Simultaneous Dissolution of Two Solid State Mixtures of Ritonavir
Physiologically-based Pharmacokinetic (PBPK) Modeling Approach for the Prediction of Small Intestinal Precipitation of Poorly Soluble Drugs—A Simulation Study of Posaconazole Using the Simcyp ADAM Model
Weakly basic poorly soluble drug compounds, such as posaconazole (POSA), may dissolve completely at fasted gastric pH but precipitate upon transit to higher small intestinal pH. A number of in vitro and in vivo methods have been used to study intestinal precipitation of poorly soluble drug compounds with a varying degree of complexity. This research … Continued
Accounting for Ketoconazole Absorption Variability Improves Prediction of Its Inhibitory Effect on Midazolam Kinetics
Mechanistic Modeling Using Classical Nucleation Theory of Fluid Dynamics and Dissolution Media Effects on Supersaturation and Precipitation Behavior Based upon a USP 2 Style Transfer Apparatus: A Simulation Exercise
Incorporation of an Electrochemical Driving Force for the Renal Transport of Metformin by OCT in a Physiologically-based Pharmacokinetic Model of the Interaction between Metformin and Cimetidine
Mechanistic Model-based Analysis of Biopharmaceutics Experiments—Application of In Vitro-In Vivo Extrapolation (IVIVE) Techniques within a PBPK Modeling Framework
In vitro dissolution testing is a critical component of drug product development and is often used as a surrogate for in vivo performance. While the range of (USP) standard methods have been developed and tested for many years, no single dissolution test or apparatus comprehensively maps the in vivo behaviour of the range of compound … Continued
Revolutionizing Drug Development—d3 Medicine Joins the Certara Family
Thinking Without BordersTM Developing Medicines that MatterTM These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’ Delivering on our clients’ mission The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which … Continued
US Environmental Protection Agency Uses Certara’s Simcyp Simulator to Support Toxicological Triage
PRINCETON, NJ – Nov. 10, 2016 – Certara today announced that the U.S. Environmental Protection Agency (EPA) is using its Simcyp Population-based Simulator to support the Agency’s high-throughput toxicity testing program.