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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

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

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