Nikunjkumar Patel

Predicting Diclofenac Systemic and Synovial Fluid Concentrations After Dermal Application Using the Multi-phase Multi-layer MechDermA PBPK Model

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Modeling & Simulation for Drug Development & Formulation

A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.

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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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Commentary on “In Silico Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically-based Absorption Models”

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Early Assessment of Proarrhythmic Risk of Drugs Using the In Vitro Data and Single-cell-based In Silico Models: Proof of Concept

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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

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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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In Vitro/In Vivo Extrapolation (IVIV_E) of API Dissolution within a PBPK Framework

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Towards Development and Validation of the Dermal PBPK Model for Virtual Bioequivalence—Model Description and Validation Case Studies

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Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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