Recently Published Posters

Establishment of Virtual Bioequivalence Using Population-Based PBPK Modelling: Application to the Setting of Dissolution Limits

Author(s): Shriram M. Pathak , Nikunjkumar Patel , Janak Wedagedera, David B. Turner, Masoud Jamei, Amin Rostami-Hodjegan
Year: 2015

In vitro - in vivo correlation (IVIVC) is a biopharmaceutical tool widely used in formulation development and quality control of extended release (ER) formulations. A validated IVIVC can be used to set dissolution limits and as a surrogate for an in vivo study. Recent advances in physiologically-based pharmacokinetic (PBPK) modeling have enabled the translation of in vitro dissolution data to the prediction of in vivo performance of drug product for a patient “population”. This study demonstrates how a PBPK modelling approach can be used to 1 ) specify the upper (UL) and lower limits (LL) of dissolution for tramadol ER formulations and, 2 ) build a formulation design space based upon Weibull parameters. 

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In Silico Modelling of In vitro Bidirectional Transport Studies and Comparison to Conventional Data Analysis

Author(s): Burt H.J., Neuhoff S.
Year: 2015

Using danazol (DNZ), a high permeability-low solubility BCS II drug, the following work demonstrates the use of PBPK models to support canine therapeutic drug product development. Simcyp Dog Version 14 is an in silico PBPK simulator which combines mechanistic modeling and simulation with in vitro - in vivo extrapolation (IVIVE) to predict drug pharmacokinetics in the beagle dog. The Simulator combines the various aspects of ‘Systems Data’ and ‘Drug Data’ along with specifics of the ‘Trial Design’ to predict ‘what if?’ scenarios using a mechanistic ‘Bottom Up’ approach. 

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Pharmacokinetics of WCK 2349 in Patients with Complicated Skin & Soft Tissue Infections (cSSTIs) Caused by Gram Positive Bacteria Including MRSA

Author(s): Shailly Mehrotra, Vijay Ivaturi, Joga Gobburu, Rakesh Chugh, Ashima Bhatia
Year: 2015

Estimates of effective drug permeability that are used in PBPK models are often derived from apparent permeability (Papp ) estimates from in vitro Transwell® studies. The conventional analysis of such studies assumes that sink conditions are maintained, which can be difficult to achieve experimentally, particularly for high permeability compounds. Modeling approaches which account for the changes in drug concentration in both donor and receiver wells over time are not limited by this assumption. In the current study, bidirectional transport experiments for metoprolol, a high permeability compound with no active transport, were analyzed using the conventional approach and with a three-compartment (3C) model. 

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Pharmacokinetics of WCK 2349 in Patients with Complicated Skin & Soft Tissue Infections (cSSTIs) Caused by Gram Positive Bacteria Including MRSA

Author(s): Shailly Mehrotra, Vijay Ivaturi, Joga Gobburu, Rakesh Chugh, Ashima Bhatia
Year: 2015

The global spread of methicillin resistant Staphylococcus aureus (MRSA) in hospitals and, more recently, in communities is an unmet medical need. WCK 2349, a novel fluoroquinolone, is being developed by Wockhardt as an oral anti-MRSA agent. This study evaluated the pharmacokinetics (PK) of WCK 2349 after multiple oral dosing in selected subjects with complicated skin and soft tissue infections (cSSTIs) caused by Gram positive bacteria including MRSA.

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GGplot-Shiny: A Shiny App That Facilitates Data Manipulation And Exploration

Author(s): Samer Mouksassi, Devin Pastoor
Year: 2015

The objectives of developing this Shiny application were two-fold: 1) to develop an application that enables non-R users to manipulate their data and to produce graphics using modern R packages ggplot2 and dplyr. and 2) to provide a reference extensible application that demonstrates many of the elements required for future applications in the field.

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