Mechanistic Model-Based Analysis of Biopharmaceutics Experiments – Application of In Vitro in Vivo Extrapolation (IVIV_E) Techniques Within A PBPK Modelling 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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An Integrated Approach to Mechanistically Model In Vitro Experiments and Incorporate Drug-specific Parameter Estimates within a PBPK Framework to Simulate In-Vivo Drug Dissolution

In vitro dissolution testing is a critical component of drug product development programs and is often used as a surrogate for in vivo performance. Consequently, mechanistic modelling of in vitro dissolution studies and informed data interpretation early in the formulation development process is crucial. The Simcyp In Vitro (Data) Analysis (SIVA) toolkit is a standalone […]

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Physiologically-Based Pharmacokinetic (PBPK) Modelling 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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Animal versus human oral drug bioavailability: do they correlate?

Oral bioavailability is a key consideration in development of drug products, and the use of preclinical species in predicting bioavailability in human has long been debated. In order to clarify whether any correlation between human and animal bioavailability exist, an extensive analysis of the published literature data was conducted. Due to the complex nature of bioavailability calculations inclusion criteria were applied to ensure integrity of the data. A database of […]

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Pharma Leaders in China Embrace Simcyp Science

Bo Liu

Will the 21st century go down in history as the “Chinese Century”? If the status of its pharmaceutical industry is a barometer for China’s global position, then the answer may be “yes.” The size of the Chinese pharmaceutical market is second only to the US. In 2014, it was worth $105 billion. By 2020, the Chinese market is expected to balloon to $200 billion and dominate Asia.

Big Pharma (e.g. GSK, AstraZeneca, Roche, Pfizer, Sanofi and Novartis) is capitalizing on this projected growth by setting up more and more Chinese research centers. Scientists at these centers are keen to learn how to apply modeling and simulation to their drug development programs.

One approach to modeling and simulation— physiologically-based pharmacokinetic (PBPK) modeling— has been used to optimize dosing and clinical trial designs. As PBPK models are getting more and more complex, scientists will require extensive training on both the theoretical and practical aspects of using tools such as the Simcyp Simulator, the gold standard. In this blog post, I will discuss my recent experience as a tutor for an educational workshop in Shanghai, China and reflect on their changing landscape for modeling and simulation.

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Topics: PBPK Modeling and Simulation
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