Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

Nikunjkumar Patel

The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both differences in human and animal physiology as well as ethical concerns over animal testing have […]

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Topics: PBPK Modeling & Simulation

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 […]

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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 […]

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