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PBPK Is Ready for NDA- and IND-related Submissions! But Are YOU Ready for PBPK?

Recently, the US Food and Drug Administration held a workshop on “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection.” With the FDA’s intention to maintain an efficient review process for human drug and biological products, PBPK models may be useful for assessing risk during drug development. Indeed, PBPK models have increasingly been applied […]

Speaker(s): Amin Rostami-Hodjegan
Solution: Model-informed Drug Development, PBPK Modeling & Simulation
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A Student’s Perspective on Using Phoenix NLME for PopPK Analysis of an Intranasal Combination Drug

The pharmacokinetic dispositions and the underlying variability of Kovacaine Mist®, a combination product containing oxymetazoline and tetracaine, were investigated by nonlinear mixed effects modeling using Phoenix® NLME. The project utilized the different plugins in the Phoenix platform allowing all steps of model development right from data setup to producing publication quality graphs in a single […]

Speaker(s): Tim Cacek
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System
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Quantitative and Systems Pharmacology Approaches for the Development of Oncology Drugs

Modeling and simulation of the absorption, distribution, metabolism and elimination (ADME) of a drug, using a mechanistic approach, can help to predict the potential exposure of a drug at a given dose in the population of interest. The development of in vitro – in vivo extrapolation (IVIVE) relating to ADME to predict pharmacokinetic (PK) parameters […]

Speaker(s): Karen Rowland Yeo
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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How Using Phoenix Can Halve the Time Spent on Pre-clinical PK Analyses

WinNonlin was launched in 1986 and has become the de facto standard for NCA and PK/PD modeling. Four years ago, Phoenix WinNonlin was launched to very positive response from the scientific community. As we worked closely with the WinNonlin user community to design the next generation Phoenix platform, we realized that users were spending much […]

Speaker(s): Christopher Mehl
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
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Managing Pre-clinical Study Data as a Strategic Asset

In this webinar, David Lowis, D. Phil. of Certara, makes the case for adopting a solution that allows immediate access, visualization and analysis of pre-clinical data for optimized decision making, while leveraging the FDA mandated CDISC-SEND data standard. Joining Dr. Lowis will be Stuart Horowitz, PhD, President of Institutional Services at WIRB-Copernicus Group. Dr. Horowitz […]

Speaker(s): David Lowis
Solution: Scientific Informatics
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Phoenix WinNonlin: A State of the Art Software Tool for Pre-clinical PK and TK Analysis

Are you currently using Excel for PK/TK analysis? Phoenix WinNonlin streamlines analyses and generates all of the output needed for non-compartmental analysis, TK, PK and PK/PD studies from within a single, validatable environment. Highlights of this webinar included: Sophisticated plotting of PK data Calculation of key PK parameters Cmax, Tmax, AUClast, AUCinf, Clearance Statistical summary […]

Speaker(s): Christopher Mehl
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
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Introduction to Population PK/PD Analysis Using Phoenix NLME

Phoenix NLME provides sophisticated algorithms and powerful and flexible data processing and modeling tools for population PK/PD analyses with an intuitive graphical user interface. The Phoenix system can be customized for any type of modeler from beginners to experts. Phoenix NLME is easy to learn as it has built-in PK/PD libraries that can be used […]

Speaker(s): Serge Guzy
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
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Powering Pediatric Studies to Meet FDA Criteria

Effective medications are a mainstay of modern pediatric medicine. Yet, ethical concerns about conducting clinical trials in pediatric patients are a major challenge in pediatric drug development. Learn how Dr. Samer Mouksassi and his team at Certara Strategic Consulting have overcome these challenges through the use of pharmacometrics.

Speaker(s): Samer Mouksassi
Solution: Clinical Trials Simulation, Model-informed Drug Development, PK/PD Modeling & Simulation
Therapeutic Area: Pediatrics
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